FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10620974001376
·
Model: NC-2025-8F
·
Southmedic Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- NA
- Primary DI
- 10620974001376
- Version / Model
- NC-2025-8F
- Catalog Number
- NC-2025-8F
- Company Name
- Southmedic Incorporated
- Labeler DUNS
- 246848147
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- b4ec2d53-8c29-4cbd-8ac3-4003339f7fd9
Device Description
CO2/O2 Nasal Cannula with 7ft O2 and CO2 tube
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 10620974001376 | GS1 | ||||
| Unit of Use | 00620974001379 | GS1 |
Customer Contacts
- Phone
- +1(705)726-9383
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131410 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 7ft CO2 SAMPLING LINE, FEMALE LUER, 7ft OXYGEN TUBING WITH UNIVERSAL CONNECTOR |