FDA UDI
In Commercial Distribution
🇺🇸 United States
1240 O2 DISS Regulator TAV
DI: 00817131020254
·
Model: 10-09779-XX-01
·
INOGEN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 1240 O2 DISS Regulator TAV
- Primary DI
- 00817131020254
- Version / Model
- 10-09779-XX-01
- Company Name
- INOGEN, INC.
- Labeler DUNS
- 136729634
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-13
- Public Version
- 1
- Public Version Date
- 2020-03-23
- Public Version Status
- New
- Public Device Record Key
- fc57695a-7a11-40e1-bf4a-f32f90171445
Device Description
1240 O2 DISS Regulator TAV, 10-09779-XX-01 and RP-1004
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| ONZ | Mechanical Ventilator | Anesthesiology | 868.5895 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45110 | Oxygen quick-connect coupling, male | A male connecting device used to connect to a medical gas pipeline system or other gas source allowing a user to rapidly connect and disconnect oxygen (O2) dependent devices to the O2 supply. It has safety features such as a specific mechanical mating pattern, colour coding and a dedicated tube diameter connection to prevent wrong connection. It is used to connect into an O2 terminal unit or female connector. It can be designed as a diameter-indexed safety system (DISS) connector or a non-interchangeable screw-threaded (NIST) connector. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817131020254 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152664 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity