FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TUB25
DI: 36642240001772
·
Model: TUB-25
·
Inogen, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- TUB25
- Primary DI
- 36642240001772
- Version / Model
- TUB-25
- Catalog Number
- CON-2501
- Company Name
- Inogen, Inc.
- Labeler DUNS
- 136729634
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-12
- Public Version
- 3
- Public Version Date
- 2025-08-20
- Public Version Status
- Update
- Public Device Record Key
- f80d174c-27e9-44c6-a8cc-dddaa707b61f
- Distribution End Date
- 2025-03-12
Device Description
1 single patient use expiratory kit, composed of 1 tube, 1 filter programmed to allow 25 therapy sessions and 3 reusable mouthpieces
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
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| SDT | Intra-Pulmonary Percussive Vibration (Ipv) Devices | Anesthesiology | 868.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48000 | Vacuum-assisted airway secretion-clearing system | A mains electricity (AC-powered) device assembly designed to remove excessive secretion [mucus or sputum (phlegm)] from the lungs and upper airway of patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)] or during cardiac rehabilitation. It consists of an electrical pump connected via a connecting tube to a hand-held venturi valve with attached mouthpiece. It functions through vacuum technology that accelerates the air exhaled by the patient; this helping to loosen the mucus for expectoration. No medication is involved. It may be used in a medical facility or the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 36642240001772 | GS1 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 55 Degrees Celsius