FDA UDI
In Commercial Distribution
🇺🇸 United States
C-MATT
DI: 00815073020004
·
Model: H12083
·
CASCO MANUFACTURING SOLUTIONS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- C-MATT
- Primary DI
- 00815073020004
- Version / Model
- H12083
- Catalog Number
- H12083
- Company Name
- CASCO MANUFACTURING SOLUTIONS, INC.
- Labeler DUNS
- 004253936
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-05
- Public Version
- 1
- Public Version Date
- 2019-04-15
- Public Version Status
- New
- Public Device Record Key
- 80814fcc-d67c-475f-abc5-6cece639dbc8
Device Description
Versa Care Foam Replacement Mattress
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IKY | MATTRESS, FLOTATION THERAPY, NON-POWERED | General Hospital | 880.5150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36067 | Flame-resistant bed mattress | A large, durable, fabric case filled with a resilient material designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep; it is also designed to retard flames in case of fire. The device provides no special therapeutic effect. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815073020004 | GS1 |