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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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Portable LED Light Source - 00874485000318

No Description
COGENTIX MEDICAL, INC.
BLS-1000
In Commercial Distribution

  • 00874485000318 ()
07-3050

  • Endoscopic light source unit, battery-powered

Genesis RapidWeld II STW Sterile Tube Welder - 00866305000264

The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430-02
In Commercial Distribution

  • 00866305000264 ()

  • Length: 33 Centimeter
  • Height: 9.9 Centimeter
  • Width: 14.2 Centimeter
  • Weight: 2.5 Kilogram
480-RW-2607-02

  • Laboratory tubing welder

Total Containment Device (TCD) - 00866305000219

The TCD B40 is a bench top, portable device intended for use by appropriately trained and qualified personnel in hospital/laboratory/clinical settings for the purpose of making sterile connections of 3.9 mm to 4.5 mm PVC tubing in blood processing applications.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 00866305000219 ()

  • Weight: 1.6 Kilogram
  • Width: 9.1 Centimeter
  • Length: 27.2 Centimeter
  • Height: 5.9 Centimeter
480-B40-00-1245

  • Laboratory tubing welder

Genesis RapidWeld STW Sterile Tube Welder - 00866305000202

The Genesis Rapid Weld STW is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 00866305000202 ()

  • Weight: 2.5 Kilogram
  • Width: 14.2 Centimeter
  • Height: 9.9 Centimeter
  • Length: 33 Centimeter
480-RW-2607-00

  • Laboratory tubing welder

CompoDock - 04086000860215

The CompoDock is used for the production of special cellular blood components, e.g. in blood banks where tube connections are needed that provide protection against microbial contamination. The CompoDock is a high-frequency connection device that permits sterile connection of medical PVC tubes to one another. Here, sterile connection is achieved when germs from the environment are prevented from being carried into the closed systems. The closed system is maintained after the docking process.
Fresenius Kabi AG
9028721
In Commercial Distribution

  • 04086000860215 ()
9028721

  • Laboratory tubing welder

Marina Medical - 00840306825132

LED Light Source, Storz Connection
MARINA MEDICAL INSTRUMENTS, INC.
250-800
In Commercial Distribution

  • 00840306825132 ()
250-800

  • Endoscopic light source unit, battery-powered

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

Pen LED - 08033638801048

Pen-LED-light for Sapi Med anoscopes, rectoscopes and retractors.
SAPI MED SPA
Pen LED light
In Commercial Distribution

  • 08033638801055 ()
  • 08033638801048 ()
B.0306

  • Endoscopic light source unit, battery-powered

mytaMed - B351MVLLS4LBTP0

Rover IV Portable LED Light Source Complete with Charger and Batteries
Mytamed, Inc.
mV-LLS-4LBTP
Not in Commercial Distribution

  • B351MVLLS4LBTP0 ()
mV-LLS-4LBTP

  • Endoscopic light source unit, battery-powered

Fenwal Hand Sealer - 00810020441062

The Hand Sealer is used to provide a hermetic closure on Blood-Pack Unit tubings when used with the Fenwal Hand Sealer Clips, code 4R4418.
Fresenius Kabi AG
4R4454W
In Commercial Distribution

  • 00810020441062 ()
4R4454W

  • Laboratory tubing welder

BMS - 06976052440092

Sterile Tube Welder
Wuhan BMS Medicaltech Co., Ltd
STW6810-RFID
In Commercial Distribution

  • 06976052440092 ()


  • Laboratory tubing welder

BMS - 06976052440061

Metal Wire Cassette is a disposable part of Sterile Tube Welder
Wuhan BMS Medicaltech Co., Ltd
Metal Wire Cassette
In Commercial Distribution

  • 16976052440068 ()
  • 06976052440061 ()


  • Laboratory tubing welder

Heating tube set for insufflation, reusable - 04056702000080

No Description
W.O.M. World of Medicine GmbH
Z1415-01
In Commercial Distribution

  • 04056702000080 ()


  • Laparoscopic insufflator

Elixir MD - 00860013019402

No Description
Elixir M.D. Inc.
LED Light Therapy Device
In Commercial Distribution

  • 00860013019402 ()


  • Blue/red/infrared phototherapy lamp

NURYSH - 00855950007049

A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.
UPLEVITY LLC
LYFT3
In Commercial Distribution

  • 00855950007049 ()


  • Blue/red/infrared phototherapy lamp

CurrentBody Skin™ - 00695866567110

The LED Eye Perfector (Model: EY-36B) is an Over-the-Counter (0TC) device intended for use in treating wrinkles within the periorbital region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
EY-36B
In Commercial Distribution

  • 00695866567110 ()


  • Blue/red/infrared phototherapy lamp

Dr Naomi - 00856957008022

The LED Light Therapy Mask (Models: MK-04) is an over the counter device that is intended forthe use in the treatment of full-face wrinkles.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
MK-04
In Commercial Distribution

  • 00856957008022 ()


  • Blue/red/infrared phototherapy lamp

Soli-Lite LG4 Galileo - 00667259003895

No Description
Silhouet-Tone Corporation
411569
In Commercial Distribution

  • 00667259003895 ()


  • Blue/red/infrared phototherapy lamp

Orbital LED Mask - 00858830007061

LED light for the treatment of wrinkles
PULSADERM LLC
RB2015
In Commercial Distribution

  • 00858830007061 ()


  • Blue/red/infrared phototherapy lamp

Celluma - 00850523007891

4 mode full body panel
Biophotas, Inc.
Series 2 DELUX C/US
In Commercial Distribution

  • 00850523007891 ()
CDL2-001

  • Blue/red/infrared phototherapy lamp

Celluma - 00850523007808

2-mode large panel
Biophotas, Inc.
Series 2 SKIN C/US
In Commercial Distribution

  • 00850523007808 ()
CSK2-001

  • Blue/red/infrared phototherapy lamp

Celluma - 00850523007754

2 mode small panel
Biophotas, Inc.
Series 2 FACE C/US
In Commercial Distribution

  • 00850523007754 ()
CLF2-001

  • Blue/red/infrared phototherapy lamp

Celluma - 00850523007730

3 mode small panel light therapy device
Biophotas, Inc.
Series 2 RESTORE C/US
In Commercial Distribution

  • 00850523007730 ()
CLR2-001

  • Blue/red/infrared phototherapy lamp

Celluma - 00850523007716

3 mode large panel light therapy device
Biophotas, Inc.
Series 2 PRO C/US
In Commercial Distribution

  • 00850523007716 ()
CLP2-001

  • Blue/red/infrared phototherapy lamp

Celluma - 00850523007501

Hand held device 3-mode
Biophotas, Inc.
POD C/US
In Commercial Distribution

  • 00850523007501 ()
CPOD-001

  • Blue/red/infrared phototherapy lamp

Celluma - 00850523007303

No Description
Biophotas, Inc.
Elite C/US
In Commercial Distribution

  • 00850523007303 ()


  • Blue/red/infrared phototherapy lamp
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