FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Somanetics
DI: 10817357020547
·
Model: SAFB-SM
·
HYGIA HEALTH SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Somanetics
- Primary DI
- 10817357020547
- Version / Model
- SAFB-SM
- Company Name
- HYGIA HEALTH SERVICES, INC.
- Labeler DUNS
- 177939027
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2021-03-19
- Public Version Status
- Update
- Public Device Record Key
- c525463c-13dc-4727-ab38-5e0c8c4e5298
- Distribution End Date
- 2019-07-31
Device Description
Cerebral/Somatic Oximetry Adult Sensor
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| NMD | Oximeter, Tissue Saturation, Reprocessed | Cardiovascular | 870.2700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46617 | Tissue saturation oximeter sensor, reprocessed | A photoelectric device that is applied externally to a site on the body surface of a paediatric or adult patient for transcutaneous measurement the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. It is connected to a tissue saturation oximeter via a fibreoptic cable. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30817357020541 | GS1 | Box | 20 | Not in Commercial Distribution | 2021-03-19 |
| Primary | 10817357020547 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100523 | 000 |