AccessGUDID - DEVICE: First Responder (00743537000197)

GUDID

Device Identifier (DI) Information

Brand Name: First Responder
Version or Model: G9672C-4.00.000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G9672C-4.00.000
Company Name: WATER-JEL TECHNOLOGIES, L.L.C.

Primary DI Number: 00743537000197
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 155522589 *Terms of Use

Device Description: First Responder Heat Shield 8'x6', 4 Canisters/cs; BD Gel

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47696	Pure wool burn sheet	A covering designed to treat large to massive patient burns made of pure new woven wool impregnated with wound gel (e.g., hydrogel) and applied over the burn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is available in various sizes [e.g., towel to blanket (sheet)] and may also be used to smother small flames. It is typically used by emergency medical services (EMS) and critical care units, but may also be used in the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPY	Sheet, Burn

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 321c0294-dde5-44c6-a105-8e0ab3e0fd67
Public Version Date: November 04, 2024
Public Version Number: 1
DI Record Publish Date: October 25, 2024