FDA UDI
In Commercial Distribution
🇺🇸 United States
Coulmed
DI: 10810087352186
·
Model: THR02
·
Coulmed Products Group LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Coulmed
- Primary DI
- 10810087352186
- Version / Model
- THR02
- Catalog Number
- THR02
- Company Name
- Coulmed Products Group LLC
- Labeler DUNS
- 047115479
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-06
- Public Version
- 1
- Public Version Date
- 2023-01-16
- Public Version Status
- New
- Public Device Record Key
- 3faf21f4-3fbe-4d7d-bf40-f79f031282f7
Device Description
Replacement Pad for Hill-Rom 881 Stretcher: 3"T Standard Foam with 4-Way Stretch Conductive Covering. 27"W x 76"L x 3"T
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 | 10810087352186 | GS1 |