FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Nonin
DI: 00833166008241
·
Model: NCell
·
NONIN MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Nonin
- Primary DI
- 00833166008241
- Version / Model
- NCell
- Company Name
- NONIN MEDICAL, INC.
- Labeler DUNS
- 174959692
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-13
- Public Version
- 5
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- 97b871a7-d0dd-476f-8cb4-db99ac58f35c
- Distribution End Date
- 2019-04-18
Device Description
N Cell Battery
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 |
|---|---|---|---|---|
| DQA | Oximeter | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36534 | Portable/mobile rechargeable battery pack | A group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00849686070323 | GS1 | Bag | 1 | Not in Commercial Distribution | 2019-04-18 |
| Primary | 00833166008241 | GS1 |
Customer Contacts
- Phone
- 763 553 9968
- [email protected]