AccessGUDID - DEVICE: FHC Stretcher Pad 26 X 76 X 4 (B337BB26X76X41)

GUDID

Device Identifier (DI) Information

Brand Name: FHC Stretcher Pad 26 X 76 X 4
Version or Model: BB26X76X4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BB26X76X4
Company Name: FUTURE HEALTH CONCEPTS, INC.

Primary DI Number: B337BB26X76X41
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 037304144 *Terms of Use

Device Description: Fhc Stretcher Pad 26” X 76” X 4” Poly Foam With Two Angled Corners And Two Rounded Corners With Dura-Comfort Material With 2” Wide Loop Velcro Sewn To Bottom Of The Pads And Mating Adhesive Hook Velcro Supplied Just Peel The Adhesive And Place The Pad Onto Stretcher.

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
36063	Stretcher mattress	A large, flat, cushion or pad with a strong cover filled with a resilient material (e.g., foam rubber) designed to be used on a stretcher to provide patient comfort whilst they lie upon it. It is much thinner than a bed mattress and is placed on top of, and typically secured to, the stretcher support platform covering this area. This is a general-purpose device that has no special therapeutic purpose.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LWG	Surgical Table Cushion

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: 3ed8b5ef-0577-455e-a962-f1ed46d92e1b
Public Version Date: September 30, 2020
Public Version Number: 1
DI Record Publish Date: September 22, 2020