FDA UDI
In Commercial Distribution
🇺🇸 United States
NAZORCAP Sampler
DI: 00856824006038
·
Model: Model No. 9801-FB
·
Nasorcap Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NAZORCAP Sampler
- Primary DI
- 00856824006038
- Version / Model
- Model No. 9801-FB
- Company Name
- Nasorcap Medical, Inc.
- Labeler DUNS
- 803689769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-08
- Public Version
- 6
- Public Version Date
- 2024-01-23
- Public Version Status
- Update
- Public Device Record Key
- 90d1b990-7905-4a3c-9409-15e09b5e2431
Device Description
Nasal ETCO2 Cannula with female luer connector.
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | 868.1400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36306 | Nasal oxygen cannula, carbon-dioxide-sampling | A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10856824006035 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 00856824006038 | GS1 |
Customer Contacts
- Phone
- 412-855-6916
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K911970 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place.