FDA UDI
In Commercial Distribution
🇺🇸 United States
Composite Respiratory Kit- Medical West
DI: 00709078003608
·
Model: 0713
·
WESTMED, INC.
Product Codes
3
GMDN Terms
3
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Composite Respiratory Kit- Medical West
- Primary DI
- 00709078003608
- Version / Model
- 0713
- Company Name
- WESTMED, INC.
- Labeler DUNS
- 092673953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-24
- Public Version
- 5
- Public Version Date
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- 0b28801e-a070-41b7-bb4f-4653e305e5c4
Device Description
2 - Packaged 25' O2 Tubing (0025), 6 - Packaged Soft Cannula with 7' Tubing (0556), 1 - Swivel Connector (0590), 1 - Barbed Connector (40076).
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OGL | Oxygen Administration Kit | Anesthesiology | 868.5655 | 2 |
| CAT | Cannula, Nasal, Oxygen | Anesthesiology | 868.5340 | 1 |
| BYX | Tubing, Pressure And Accessories | Anesthesiology | 868.5860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35201 | Nasal oxygen cannula, basic | 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 administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device. | No | Active |
| 60856 | Oxygen administration kit | A collection of devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device. | No | Active |
| 12875 | Oxygen administration tubing | A length of flexible noninvasive tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2), or an O2 enriched gas, to a mask or nasal cannula (not included), during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10709078003605 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00709078003608 | GS1 |