AccessGUDID - DEVICE: Sterile Burn Blanket (00857048006200)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile Burn Blanket
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HHSBB01
Company Name: H&H MEDICAL CORPORATION

Primary DI Number: 00857048006200
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 072656713 *Terms of Use

Device Description: H&H Sterile Burn Blanket, a mylar non-adherent sheet sterilized for use in wrapping large burn areas and protecting them from heat and moisture loss.

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?
59215	Non-adherent bed sheet	A large piece of sterile material intended to cover the mattress of a bed occupied by a patient receiving open-wound treatment, primarily in cases of wounds that have breached the dermis (e.g., extensive burns, cauterizations, and abrasions). It is typically composed of a skin-contact surface (e.g., aluminized, non-woven fabric) designed to prevent adherence to wounds, and thus decrease the potential for trauma, with multiple additional layers designed to diffuse/absorb wound exudate. 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: Yes
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: 441797ed-8910-46a0-b558-cbff635079d0
Public Version Date: January 08, 2021
Public Version Number: 1
DI Record Publish Date: December 31, 2020