FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 10885632130465
·
Model: RSP6120A
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 10885632130465
- Version / Model
- RSP6120A
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-05
- Public Version
- 2
- Public Version Date
- 2022-03-22
- Public Version Status
- Update
- Public Device Record Key
- d0b2cbe5-30fb-4515-85a2-ed53c1c35e0e
Device Description
Cannula Carbon Dioxide Oxygen Sampling Comfort Soft Plus 7 Foot Tubing With Female Luer Universal Connector Adult Not Made With Natural Rubber Latex MediChoice
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
- 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
- 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 |
|---|---|---|---|---|
| CAT | CANNULA, NASAL, OXYGEN | Anesthesiology | 868.5340 | 1 |
| 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 | 50885632130463 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 10885632130465 | GS1 |