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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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DG Spin - 08437014205152

DG SPIN Centrifugue is a device specifically designed to centrifuge DG Gel 8 cards.
DIAGNOSTIC GRIFOLS SA
210363
In Commercial Distribution

  • 08437014205152 ()
210363

  • Gel column agglutination centrifuge IVD

ID CORE XT - 08437013457019

ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology. The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution

  • 08437013457019 ()
1021720000

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)

Blood Typing Manager - 08436583730980

Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System. Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System as part of the DG Gel System.
DIAGNOSTIC GRIFOLS SA
210404
Not in Commercial Distribution

  • 08436583730980 ()
210404

  • Blood bank information system application software

TCD B40 Wafers - 10866305000278

The TCDB40 Wafer Assembly consists of a copper wafer and plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion. The wafer assembly is placed in the TCDB40 Sterile Tube Welding device prior to the weld process. The copper wafer is separated from the plastic holder during the welding process and after welding is completed both the plastic holder and the copper wafer are removed from the device and discarded. The wafers are single use only and cannot be reused. The TCDB40 Sterile Tube Welding device will not operate without a wafer assembly inserted and will not operate with a used a wafer. The TCDB40 wafer assemblies are packaged in 8 plastic trays. Each tray has 25 individual wafer assemblies. Each box referred to as a case has a total of 200 individual TCDB40 wafer assemblies.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 10866305000278 ()
  • 00866305000271 ()
480-B40-00-2038

  • Laboratory tubing welder

RapidWeld Blade Module Kit - 10866305000254

The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000254 ()
  • 00866305000257 ()
480-RW-2478-03

  • Laboratory tubing welder

RapidWeld Blade Module Kit - 10866305000247

The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000247 ()
  • 00866305000240 ()
480-RW-2478-02

  • Laboratory tubing welder

RapidWeld Blade Module Kit - 10866305000230

The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis RapidWeld STW, Model GRW-430 will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000230 ()
  • 00866305000233 ()
480-RW-2478-01

  • Laboratory tubing welder

TCD B40 Wafers - 10866305000223

The TCD B40 Wafer Assembly consists of a copper wafer and a plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion.The wafer assembly is placed in the device prior to the weld process. During the welding process the copper wafer is separated from the plastic holder, and after welding is completed, both the holder and wafer are removed from the device and discarded. The wafers are one-time use only and cannot be reused. The TCD B40 device will not operate without a wafer assembly inserted and will not operate with a used wafer. The TCD B40 wafer assemblies are packaged in boxes containing 240 wafer assemblies in each box referred to as a case.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 10866305000223 ()
  • 00866305000226 ()
480-B40-00-1274

  • Laboratory tubing welder

S-Monovette® - 04038917228305

S-Monovette® 8.8 ml ACD-A
Sarstedt Aktiengesellschaft & Co.KG
01.1624.001
In Commercial Distribution

  • 04038917228299 ()
  • 04038917228305 ()
  • 04038917228312 ()
01.1624.001

  • Non-evacuated blood collection tube IVD, anticoagulant

Alere Determine™ HIV–1/2 Ag/Ab Combo Controls - 10811877010347

The Alere Determine™ HIV-1/2 Ag/Ab Combo Controls are quality control reagents for use with the Alere Determine™ HIV-1/2 Ag/Ab Combo Assay only.
Alere Scarborough, Inc.
7D2628
Not in Commercial Distribution

  • 10811877010347 ()


  • HIV1/HIV2 antigen/antibody IVD, control

Alere Determine™ HIV–1/2 Ag/Ab Combo - 10811877010323

Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2649
Not in Commercial Distribution

  • 10811877010323 ()


  • HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical

Alere Determine™ HIV–1/2 Ag/Ab Combo - 10811877010293

Alere Determine™ HIV–1/2 Ag/Ab Combo is an in vitro, visually read, qualitative immunoassay for the simultaneous detection of HIV-1 p24 antigen (Ag) and antibodies (Ab) to HIV-1 and HIV-2 in human serum, plasma, capillary (fingerstick) whole blood or venipuncture (venous) whole blood.
Alere Scarborough, Inc.
7D2648
Not in Commercial Distribution

  • 10811877010293 ()


  • HIV1/HIV2 antigen/antibody IVD, kit, rapid ICT, clinical

Haemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems - 10812747011686

BMB PLS Bowls
HAEMONETICS CORPORATION
0625B-00
In Commercial Distribution

  • 30812747011680 ()
  • 10812747011686 ()

  • Total Volume: 275 Milliliter


  • Apheresis system tubing set

Typesafe - 10812269031285

Typesafe Segment Piercing Device
TYPENEX MEDICAL LLC
4R4750
In Commercial Distribution

  • 00812269031295 ()
  • 10812269031285 ()
  • 00812269031288 ()


  • Blood donor bag segment sampling IVD

Typesafe 2.0 - 10812269031254

Typesafe 2.0 - Quantity 1000
TYPENEX MEDICAL LLC
SP0201QM
In Commercial Distribution

  • 00812269031264 ()
  • 10812269031254 ()
  • 00812269031257 ()


  • Blood donor bag segment sampling IVD

Cryostore - 10816203021547

Cryostore 2500 Conical EVA Freezing Bag, 730-810ml, " Y14" Tubing Set, case of 12
ORIGEN BIOMEDICAL, INC.
CSD2500Y14
In Commercial Distribution

  • 10816203021547 ()
  • 20816203021544 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021530

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, Standard Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750
In Commercial Distribution

  • 20816203021537 ()
  • 10816203021530 ()
  • 00816203021533 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021523

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y11" Tubing Set, case of 50
ORIGEN BIOMEDICAL, INC.
CS750Y11
Not in Commercial Distribution

  • 20816203021520 ()
  • 10816203021523 ()
  • 00816203021526 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021516

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "Y10" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750Y10
Not in Commercial Distribution

  • 20816203021513 ()
  • 10816203021516 ()
  • 00816203021519 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021509

Cryostore 750 EVA 3-Bag set with drip spikes, 80-190ml, case of 6 sets
ORIGEN BIOMEDICAL, INC.
CS750V4
Not in Commercial Distribution

  • 10816203021509 ()
  • 20816203021506 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021493

Cryostore 750 EVA Freezing Bag, 80-190ml, 3- Bag set with "V3" Tube Set, 1 set per pouch, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS750V3
Not in Commercial Distribution

  • 10816203021493 ()
  • 20816203021490 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021455

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "M2" tube set, case of 12, double pouched
ORIGEN BIOMEDICAL, INC.
CS750M2S
Not in Commercial Distribution

  • 10816203021455 ()
  • 20816203021452 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021448

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F8" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750F8
Not in Commercial Distribution

  • 20816203021445 ()
  • 10816203021448 ()
  • 00816203021441 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021431

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F5" tube set, case of 20
ORIGEN BIOMEDICAL, INC.
CS750F5-2
Not in Commercial Distribution

  • 20816203021438 ()
  • 10816203021431 ()
  • 00816203021434 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021424

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, "F5" tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS750F5
Not in Commercial Distribution

  • 20816203021421 ()
  • 10816203021424 ()
  • 00816203021427 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021417

Cryostore 750 EVA Freezing Bag, 80 - 190 ml, F1 tube set, double aseptic packed, case of 12
ORIGEN BIOMEDICAL, INC.
CS750F1S
Not in Commercial Distribution

  • 10816203021417 ()
  • 20816203021414 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021400

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, "Y3" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50Y3
Not in Commercial Distribution

  • 20816203021407 ()
  • 10816203021400 ()
  • 00816203021403 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021387

Cryostore 50 EVA 4- Bag Set, 10-30ml, "Standard" Tubing Set, 1 set per pouch, case of 6
ORIGEN BIOMEDICAL, INC.
CS50V4
Not in Commercial Distribution

  • 10816203021387 ()
  • 20816203021384 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021370

Custom 50 EVA 2-Bag set with spikes, 10-30ml, 1 set per pouch, case of 12
ORIGEN BIOMEDICAL, INC.
CS50V2
In Commercial Distribution

  • 10816203021370 ()
  • 20816203021377 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021363

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, singly packed in OW
ORIGEN BIOMEDICAL, INC.
CS50SW
Not in Commercial Distribution

  • 10816203021363 ()
  • 20816203021360 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021356

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, triply packed
ORIGEN BIOMEDICAL, INC.
CS50S-3
Not in Commercial Distribution

  • 10816203021356 ()
  • 20816203021353 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021349

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS50S
In Commercial Distribution

  • 10816203021349 ()
  • 20816203021346 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021332

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, M3 tube set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50M3
In Commercial Distribution

  • 20816203021339 ()
  • 10816203021332 ()
  • 00816203021335 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021325

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 24, heat sealed
ORIGEN BIOMEDICAL, INC.
CS50H
Not in Commercial Distribution

  • 20816203021322 ()
  • 10816203021325 ()
  • 00816203021328 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021318

Cryostore 50 EVA Freezing Bag, 10-30ml, "F4" Tubing Set, double aseptically pouched, case of 12
ORIGEN BIOMEDICAL, INC.
CS50F4S
Not in Commercial Distribution

  • 10816203021318 ()
  • 20816203021315 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021271

Cryostore 50 EVA Freezing Bag, 10-30ml, "F15" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS50F15
Not in Commercial Distribution

  • 20816203021278 ()
  • 10816203021271 ()
  • 00816203021274 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021264

Cryostore 500 EVA 3-Bag set with spikes, 55-100ml, 1 set per pouch, case of 8 sets
ORIGEN BIOMEDICAL, INC.
CS500V3
Not in Commercial Distribution

  • 10816203021264 ()
  • 20816203021261 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021257

Custom 500ml EVA 2-bag set with spikes, 1 set per pouch, 12 sets per case
ORIGEN BIOMEDICAL, INC.
CS500V2P
Not in Commercial Distribution

  • 10816203021257 ()
  • 20816203021254 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021240

Custom 500 EVA 2-Bag set with spikes, 55-100ml, "V2" Tube Set, 2 sets per pouch
ORIGEN BIOMEDICAL, INC.
CS500V2
In Commercial Distribution

  • 20816203021247 ()
  • 10816203021240 ()
  • 00816203021243 ()
CS500V2

  • Blood/tissue storage/culture container

Cryostore - 10816203021233

Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed in OW
ORIGEN BIOMEDICAL, INC.
CS500SW
Not in Commercial Distribution

  • 10816203021233 ()
  • 20816203021230 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021226

Cryostore 500 EVA Freezing Bag, 55 - 100 ml Std.Tubing Set, case of 12, singly packed
ORIGEN BIOMEDICAL, INC.
CS500S
Not in Commercial Distribution

  • 10816203021226 ()
  • 20816203021223 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021219

Cryostore 500 EVA Freezing Bag, 55 - 100 ml "M4" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500M4
Not in Commercial Distribution

  • 20816203021216 ()
  • 10816203021219 ()
  • 00816203021212 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021202

Cryostore 500 EVA Freezing Bag, custom length, Standard Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500i3
In Commercial Distribution

  • 20816203021209 ()
  • 10816203021202 ()
  • 00816203021205 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021196

Cryostore 500 EVA Bag, custom-width, N-tube set, in custom-width O-Wrap, case of 12
ORIGEN BIOMEDICAL, INC.
CS500i2PW
Not in Commercial Distribution

  • 10816203021196 ()
  • 20816203021193 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021189

Cryostore 500 EVA Freezing Bag, custom width, "N" Tubing Set, case of 12
ORIGEN BIOMEDICAL, INC.
CS500i2
Not in Commercial Distribution

  • 10816203021189 ()
  • 20816203021186 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021172

Cryostore 500 EVA Freezing Bag, custom width, "N" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500i
Not in Commercial Distribution

  • 20816203021179 ()
  • 10816203021172 ()
  • 00816203021175 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021165

Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "F1" Tubing Set, double aseptic packed, case of 12
ORIGEN BIOMEDICAL, INC.
CS500F1S
Not in Commercial Distribution

  • 10816203021165 ()
  • 20816203021162 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021158

Cryostore 500 EVA Freezing Bag, 55 - 100 ml, "F16" Tubing Set, case of 24
ORIGEN BIOMEDICAL, INC.
CS500F16
Not in Commercial Distribution

  • 20816203021155 ()
  • 10816203021158 ()
  • 00816203021151 ()


  • Blood/tissue storage/culture container

Cryostore - 10816203021141

CryoStore 500 EVA Freezing Bag, 55-100ml, "Standard" Tube Set
ORIGEN BIOMEDICAL, INC.
CS500
In Commercial Distribution

  • 20816203021148 ()
  • 10816203021141 ()
  • 00816203021144 ()
CS500

  • Blood/tissue storage/culture container

Cryostore - 10816203021134

Cryostore 50 EVA Freezing Bag, 10 - 30 ml, standard tube set, case of 12, 4 per triply pouched, 3 pouches per case
ORIGEN BIOMEDICAL, INC.
CS50-3
Not in Commercial Distribution

  • 20816203021131 ()
  • 10816203021134 ()
  • 00816203021137 ()


  • Blood/tissue storage/culture container
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