AccessGUDID - DEVICE: Pad FHC 1000 Deluxe Patient Transfer Extension 18"W X 25"L X 1"T (B337BBFACC0041A1)

GUDID

Device Identifier (DI) Information

Brand Name: Pad FHC 1000 Deluxe Patient Transfer Extension 18"W X 25"L X 1"T
Version or Model: BB-FACC0041A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BB-FACC0041A
Company Name: FUTURE HEALTH CONCEPTS, INC.

Primary DI Number: B337BBFACC0041A1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 037304144 *Terms of Use

Device Description: FHC1000 Patient Transfer Extension Pad (Pressure Relief) 18"W X 25"L X 1"T. This Pad Incorporates A Layer Of Pressure Relief Viscoelastic Foam (A.K.A. Memory Foam) To Aid In The Prevention Of Pressure Ulcers During Longer Procedures The Balance Of The Foam Is High-Density Polyurethane Foam The Top Cover Material Is The Soft Stretchable Urethane-Coated Conductive Material With A Conductive Vinyl Sheeting Bottom Cover. With Velcro Kit.

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:
Requires Sterilization Prior to Use:

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: 80a6b406-a65a-42e9-88de-d19c118d4833
Public Version Date: September 24, 2020
Public Version Number: 1
DI Record Publish Date: September 16, 2020