FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04046964958335
·
Model: 8713145U-99
·
B. BRAUN MEDICAL INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04046964958335
- Version / Model
- 8713145U-99
- Catalog Number
- 8713145U-99
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2021-03-19
- Public Version Status
- Update
- Public Device Record Key
- 2e785c44-5899-4ae2-9622-f14106fa8cdc
Device Description
SPACECOVER COMFORT - US VERSION ASSET
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRN | Pump, infusion | General Hospital | 880.5725 | 2 |
| LZH | PUMP, INFUSION, ENTERAL | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36179 | Infusion pump management unit, mobile | A mains electricity (AC-powered) mobile unit designed for the bedside organization, management, monitoring and electrical supply of many infusion pumps that are being used simultaneously to supply one patient. This device will be found in the intensive care unit (ICU) and helps achieve a high degree of organization of, e.g., the different infusion pumps, syringe pumps, the infusion sets and lines and the medication being infused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964958335 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]