FDA UDI
In Commercial Distribution
🇺🇸 United States
7ft O2 Delivery Tube TAV, 1PK
DI: 00817131020384
·
Model: RP-1010
·
INOGEN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 7ft O2 Delivery Tube TAV, 1PK
- Primary DI
- 00817131020384
- Version / Model
- RP-1010
- Catalog Number
- RP-1010
- Company Name
- INOGEN, INC.
- Labeler DUNS
- 136729634
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-20
- Public Version
- 2
- Public Version Date
- 2022-08-05
- Public Version Status
- Update
- Public Device Record Key
- df432ece-52ef-48c3-ab7e-1e7608a4c4a1
Device Description
7ft O2 Delivery Tube TAV, 1PK, RP-1010
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ONZ | Mechanical Ventilator | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00817131020384 | GS1 | ||||
| Package | 00817131020322 | GS1 | RP-1001 | 3 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152664 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius