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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HOMECARE BARIATRIC BED, Height 16” - 24.5," Dimensions 42”(W) x 88”(L), Wt Limit 600 lbs. (Weight capacity includes patient weight, mattress weight, rails and any accessories).
DALTON MEDICAL CORPORATION
B-T4000
In Commercial Distribution

  • 00815027011492 ()

  • 88"L x 42"W x 16"-24.5"H


  • Basic electric home bed
HOMECARE BED LIGHTWEIGHT, SEMI-ELECTRIC, WT. LIMIT 400 lbs. (Includes patient weight, mattress, rails, proper positioning, realignment, transfer and overall care is 400 pounds).
DALTON MEDICAL CORPORATION
BED2100
In Commercial Distribution

  • 00815027011485 ()

  • 88" L x 36" W x 15"-24"H


  • Basic electric home bed
HOMECARE LOW BED, 35" W x 88" L x 8.75"-17.75" H, WT. LIMIT 400 lbs. (WT. LIMIT INCLUDES PATIENT WEIGHT, MATTRESS WEIGHT, RAILS AND ANY ACCESSORIES).
DALTON MEDICAL CORPORATION
BEDL3500
In Commercial Distribution

  • 00815027011461 ()

  • 35" W x 88" L x 8.75"-17.75" H


  • Basic electric home bed
PRESSURE MONITORING SET
Edwards Lifesciences LLC
T434501B
In Commercial Distribution

  • 57460691956631 ()
  • 07460691956636 ()

  • TOTAL VOLUME: 3 CC, LENGTH: 88 INCH (225 CENTIMETER)
T434501B

  • Invasive-pressure external transducer, single-use
PRESSURE MONITORING KIT - STERILE
Edwards Lifesciences LLC
PXVK0467
In Commercial Distribution

  • 07460691954632 ()
  • 57460691954637 ()

  • TOTAL VOLUME: 3 CC, LENGTH: 88 INCH (224 CENTIMETER)
PXVK0467

  • Arterial blood sampling kit
  • Invasive-pressure external transducer, single-use
PRESSURE MONITORING SET
Edwards Lifesciences LLC
PXVMP172AT3
In Commercial Distribution

  • 07460691950405 ()
  • 57460691950400 ()

  • TOTAL VOLUME: 3 CC, LENGTH: 88 INCH (224 CENTIMETER)
PXVMP172AT3

  • Arterial blood sampling kit
  • Invasive-pressure external transducer, single-use
PRESSURE MONITORING SET
Edwards Lifesciences LLC
T413675A
In Commercial Distribution

  • 57460691948957 ()
  • 07460691948952 ()

  • TOTAL VOLUME: 3 CC, LENGTH: 88 INCH (225 CENTIMETER)
T413675A

  • Invasive-pressure external transducer, single-use
Scanlan® SURG-I-LOOP® silicone loops - White Mini, 1.5 x .88 mm, 16"/40 cm long, Bulk Non-Sterile (20/pkg)
SCANLAN INTERNATIONAL INC
1001-81B
In Commercial Distribution

  • 00846159027785 ()
1001-81B

  • Surgical vessel loop
AtmosAir Velaris Mattress - PLUS FLEX - 1220 x 2240 x 180 mm (48 x 88 x 7 in) - Top Cover Premium
Arjohuntleigh AB
633903
In Commercial Distribution

  • 05059441364443 ()
633903

  • Alternating-pressure bed mattress overlay system
AtmosAir Velaris Mattress - PLUS FLEX - 1220 x 2240 x 180 mm (48 x 88 x 7 in) - Top Cover Reliant
Arjohuntleigh AB
633902
In Commercial Distribution

  • 05059441364436 ()
633902

  • Alternating-pressure bed mattress overlay system
Antibacterial Clear Waterproof Sterile Bandages, all one size, 2 IN x 3 1/2 IN (50 mm x 88 mm)
RITE AID CORPORATION
011822782111
Not in Commercial Distribution

  • 10011822782118 ()
  • 00011822782111 ()
  • 60011822782113 ()


  • Skin-cover adhesive strip, antimicrobial
Alternating Pressure with On-Demand Low Air Loss Expandable Mattress System, 80"-84"-88" x 36"-39"-42"-48" x 10"
KAP MEDICAL
K-2XMS
In Commercial Distribution

  • 00817012020519 ()
K-2XMS

  • Low-air-loss bed
Pulsating, Low Air Loss, Width and Length Expansion, Mattress System, 36"~39/42"~48" x 80"~84"~88" x 10".
KAP MEDICAL
Wave BB XMS
In Commercial Distribution

  • 00817012030990 ()
Wave BB XMS

  • Low-air-loss bed
Pulsating, Low Air Loss, Length and Width Expandable, Mattress System, 36"~39/42"~48", x 80"~84"~88"x 10".
KAP MEDICAL
Wave XMS
In Commercial Distribution

  • 00817012030907 ()
Wave XMS

  • Low-air-loss bed
Expandable, Alternating Rotation, Turn Assist, On-Demand Low Air Loss, Mattress System 80"`~84"~88" x 36"~42"~48" x 11".
KAP MEDICAL
U-K-6-X-MS-D-CT
In Commercial Distribution

  • 00817012030440 ()
U-K-6-X-MS-D-CT

  • Low-air-loss bed
88" (224 cm) Appx 11.1 ml, 60 Drop Admin Set w/Pre-Slit Port, 2 Clave®, Rotating Luer, 1 Ext
ICU MEDICAL, INC.
B9612
In Commercial Distribution

  • 10887709014661 ()
  • 00887709014664 ()


  • Basic intravenous administration set, noninvasive
88" (224 cm) Appx 11.1 ml, 15 Drop Admin Set w/Pre-Slit Port, 2 Clave®, Rotating Luer, 1 Ext
ICU MEDICAL, INC.
B9611
In Commercial Distribution

  • 10887709014654 ()
  • 00887709014657 ()


  • Basic intravenous administration set, noninvasive
Alternating Rotation with True Low Air Loss Expandable Mattress System, 80"-84"-88" x 36"-39"/42"-48" x 10"
KAP MEDICAL
K-ZXMS
In Commercial Distribution

  • 00817012022124 ()
K-ZXMS

  • Low-air-loss bed
T-Handle
SPINEVISION
PL1-A011
In Commercial Distribution

  • 03663136023953 ()

  • Length: 90 Milliimeters, Width: 90 Milliimeters


  • Polymeric spinal interbody fusion cage
GenetiSure Dx Cot-1 Human DNA
AGILENT TECHNOLOGIES, INC.
K1201-64400
In Commercial Distribution

  • 05700571112656 ()

  • N/A


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
GenetiSure Dx Wash Buffer 2
AGILENT TECHNOLOGIES, INC.
K1201-64310
In Commercial Distribution

  • 05700571112649 ()

  • N/A


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
GenetiSure Dx Wash Buffer 1
AGILENT TECHNOLOGIES, INC.
K1201-64305
In Commercial Distribution

  • 05700571112632 ()

  • N/A


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
GenetiSure Dx Hybridization Kit
AGILENT TECHNOLOGIES, INC.
K1201-64200
In Commercial Distribution

  • 05700571112625 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
GenetiSure Dx Labeling Kit Purification Columns
AGILENT TECHNOLOGIES, INC.
K1201-64110
In Commercial Distribution

  • 05700571112618 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
GenetiSure Dx Labeling Kit
AGILENT TECHNOLOGIES, INC.
K1201-64105
In Commercial Distribution

  • 05700571112601 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
GenetiSure Dx Postnatal Assay
AGILENT TECHNOLOGIES, INC.
K1201A
In Commercial Distribution

  • 05700571108697 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
No Description
Microgenics Corporation
TUM-S1
In Commercial Distribution

  • 00884883003804 ()


  • Multiple tissue-associated protein/tumour marker IVD, control
No Description
Microgenics Corporation
TUM-303
In Commercial Distribution

  • 00884883002463 ()


  • Multiple tissue-associated protein/tumour marker IVD, control
No Description
Microgenics Corporation
TUM-202
In Commercial Distribution

  • 00884883002456 ()


  • Multiple tissue-associated protein/tumour marker IVD, control
No Description
Microgenics Corporation
TUM-101
In Commercial Distribution

  • 00884883002449 ()


  • Multiple tissue-associated protein/tumour marker IVD, control
CytoScan™ Dx Post-PCR 15-30°C MOD E PW
Affymetrix, Inc.
902111
In Commercial Distribution

  • 00856826006166 ()
902111

  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
CytoScan™ Dx Pre-PCR 2-8°C MOD T E W
Affymetrix, Inc.
902108
In Commercial Distribution

  • 00856826006159 ()
902108

  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
CytoScan™ Dx Pre-PCR -20°C MOD R L A
Affymetrix, Inc.
902107
In Commercial Distribution

  • 00856826006142 ()
902107

  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
CytoScan™ Dx Post-PCR 2-8°C MOD S AH W PB
Affymetrix, Inc.
902110
In Commercial Distribution

  • 00856826006135 ()
902110

  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
CytoScan™ Dx Post-PCR -20°C MOD F L H
Affymetrix, Inc.
902109
In Commercial Distribution

  • 00856826006128 ()
902109

  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
CytoScan™ Dx WS B
Affymetrix, Inc.
902091
In Commercial Distribution

  • 00856826006111 ()
902091

  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
CytoScan™ Dx WS A
Affymetrix, Inc.
902090
In Commercial Distribution

  • 00856826006104 ()
902090

  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
CytoScan™ Dx Array, 6 pk
Affymetrix, Inc.
902150
In Commercial Distribution

  • 00856826006098 ()
902150

  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
CytoScan™ Dx Array
Affymetrix, Inc.
520969
In Commercial Distribution

  • 00856826006081 ()
520969

  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)
Carton Label
Rna Medical Division
Glucose and B-ketone CVC
In Commercial Distribution

  • 00851290002355 ()
70906-01

  • Glucose/ketone/lipid profile IVD, control
Bottle Label
Rna Medical Division
Glucose and B-Ketone CVC Level 5
In Commercial Distribution

  • 00851290002348 ()
70906-01

  • Glucose/ketone/lipid profile IVD, control
Bottle Label
Rna Medical Division
Glucose and B-Ketone CVC Level 4
In Commercial Distribution

  • 00851290002331 ()
70906-01

  • Glucose/ketone/lipid profile IVD, control
Bottle Label
Rna Medical Division
Glucose and B-Ketone CVC Level 3
In Commercial Distribution

  • 00851290002324 ()
70906-01

  • Glucose/ketone/lipid profile IVD, control
Bottle label
Rna Medical Division
Glucose and B-Ketone CVC Level 2
In Commercial Distribution

  • 00851290002317 ()
70906-01

  • Glucose/ketone/lipid profile IVD, control
Bottle label
Rna Medical Division
Glucose and B-Ketone CVC Level 1
In Commercial Distribution

  • 00851290002300 ()
70906-01

  • Glucose/ketone/lipid profile IVD, control
No Description
Roche Diagnostics GmbH
11776452160
In Commercial Distribution

  • 04015630938780 ()
11776452160

  • Multiple tissue-associated protein/tumour marker IVD, control
InteliQ Tumor Marker Control MiniPak (A human based assayed tumor marker control.)
BIO-RAD LABORATORIES, INC.
12008292
In Commercial Distribution

  • 03610522046072 ()
12008292

  • Multiple tissue-associated protein/tumour marker IVD, control
InteliQ Tumor Marker Control Level 3 (A human based assayed tumor marker control.)
BIO-RAD LABORATORIES, INC.
12008291
In Commercial Distribution

  • 03610522046065 ()
12008291

  • Multiple tissue-associated protein/tumour marker IVD, control
InteliQ Tumor Marker Control Level 2 (A human based assayed tumor marker control.)
BIO-RAD LABORATORIES, INC.
12008290
In Commercial Distribution

  • 03610522046058 ()
12008290

  • Multiple tissue-associated protein/tumour marker IVD, control
InteliQ Tumor Marker Control Level 1 (A human based assayed tumor marker control.)
BIO-RAD LABORATORIES, INC.
12008289
In Commercial Distribution

  • 03610522046041 ()
12008289

  • Multiple tissue-associated protein/tumour marker IVD, control
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