FDA UDI
In Commercial Distribution
🇺🇸 United States
Nonin
DI: 00849686074772
·
Model: 8004CA
·
NONIN MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Nonin
- Primary DI
- 00849686074772
- Version / Model
- 8004CA
- Company Name
- NONIN MEDICAL, INC.
- Labeler DUNS
- 174959692
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 4
- Public Version Date
- 2019-12-11
- Public Version Status
- Update
- Public Device Record Key
- b4173ac2-e853-47b4-8681-ace68e93be2e
Device Description
Single-Patient Use, Non-Sterile, Disposable Regional Oximetry Sensor with EQUANOX™ Technology
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46620 | Cerebral oximeter sensor, single-use | A photoelectric device designed to be applied externally to the scalp/head of a patient for transcutaneous measurement [e.g., using near-infrared spectroscopy (NIRS)] of brain tissue blood oxygen saturation and/or venous oxygen saturation in the brain. It connects to a cerebral oximeter via a fibreoptic cable and typically consists of a single/dual adhesive sensing strip. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00849686071405 | GS1 | Bag | 1 | In Commercial Distribution | |
| Primary | 00849686074772 | GS1 | ||||
| Package | 00849686085815 | GS1 | Box | 10 | In Commercial Distribution | |
| Package | 00833166006797 | GS1 | Box | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 763 553 9968
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -22 – 158 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 70 Degrees Celsius