FDA UDI
In Commercial Distribution
🇺🇸 United States
BED COVER KIT-INCLUDES 8X36X84-TOTALCARE SPORT CAL129-POLYURETHANE-SILVER I
DI: 00840828176743
·
Model: BMK-83684-TCS129-PU-S14
·
CURBELL MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BED COVER KIT-INCLUDES 8X36X84-TOTALCARE SPORT CAL129-POLYURETHANE-SILVER I
- Primary DI
- 00840828176743
- Version / Model
- BMK-83684-TCS129-PU-S14
- Catalog Number
- 23290
- Company Name
- CURBELL MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 796452311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-25
- Public Version
- 1
- Public Version Date
- 2020-04-02
- Public Version Status
- New
- Public Device Record Key
- 9678477c-7261-4fa1-9517-db521919a27c
Device Description
BED COVER KIT-INCLUDES 8X36X84-TOTALCARE SPORT CAL129-POLYURETHANE-SILVER I
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
- Yes
- 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 |
|---|---|---|---|---|
| FMW | Cover, Mattress (Medical Purposes) | General Hospital | 880.6190 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62365 | Bed mattress/cover set | A collection of devices designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep, and which may help to promote therapeutic postures. It typically consists of a bed mattress, mattress overlay/cover and wedge-shaped cushion which are typically made of knitted polyester, polyurethane foam, buckwheat husk or combinations of materials. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840828176743 | GS1 |
Customer Contacts
- Phone
- 18002357500
- [email protected]