FDA UDI
In Commercial Distribution
🇺🇸 United States
Pad FHC O.R.Table Pad 2 Thick (Set Of 4)
DI: B337BBFHC1000SSF1
·
Model: BBFHC1000S-SF
·
FUTURE HEALTH CONCEPTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pad FHC O.R.Table Pad 2 Thick (Set Of 4)
- Primary DI
- B337BBFHC1000SSF1
- Version / Model
- BBFHC1000S-SF
- Catalog Number
- BBFHC1000S-SF
- Company Name
- FUTURE HEALTH CONCEPTS, INC.
- Labeler DUNS
- 037304144
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-10
- Public Version
- 1
- Public Version Date
- 2020-09-18
- Public Version Status
- New
- Public Device Record Key
- 13e83cfd-8fdf-4013-9aef-3543fbd5ca75
Device Description
FHC Operating Room Table Pad (Pressure Relief) 2 Thick (Set Of 4). 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
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWG | Surgical Table Cushion | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B337BBFHC1000SSF1 | HIBCC |