FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Norwegian, Rapid Infuser, 230 V, 1000ml/min
DI: 60896128002376
·
Model: 903-00024-N
·
BELMONT INSTRUMENT CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Norwegian, Rapid Infuser, 230 V, 1000ml/min
- Primary DI
- 60896128002376
- Version / Model
- 903-00024-N
- Company Name
- BELMONT INSTRUMENT CORPORATION
- Labeler DUNS
- 078330362
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- d8cb0d7c-9c4b-44d5-9fb6-8dafaf38bcef
- Distribution End Date
- 2023-12-31
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
- 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 |
|---|---|---|---|---|
| LGZ | Warmer, Thermal, Infusion Fluid | General Hospital | 880.5725 | 2 |
| FRN | Pump, Infusion | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17907 | Warming/high-flow infusion pump | A mains electricity (AC-powered) device designed to warm and rapidly infuse blood and other solutions (e.g., crystalloid and colloid) into a patient during high-blood-loss surgical procedures; it is also used for burn and trauma cases. Maximum flow rates may exceed 1 L/min. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 60896128002376 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091855 | 000 |