FDA UDI
In Commercial Distribution
🇺🇸 United States
AincA
DI: B005003250
·
Model: 00-325
·
ANESTHESIA ASSOCIATES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AincA
- Primary DI
- B005003250
- Version / Model
- 00-325
- Catalog Number
- 00-325
- Company Name
- ANESTHESIA ASSOCIATES, INC.
- Labeler DUNS
- 002065670
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-19
- Public Version
- 5
- Public Version Date
- 2020-09-25
- Public Version Status
- Update
- Public Device Record Key
- 40f1fa06-d0ab-48c1-a7cc-896c7a142498
Device Description
Jet Ventilator, w/Flow/Trigger Valves, 0-60psi Gauge, O2 DISS Nut 5ft Inlet Hose, LuerM Lock 2ft Outlet Hose
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
- 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
- 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 |
|---|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | Anesthesiology | 868.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37498 | Respiratory oxygen therapy system | An assembly of devices designed to be interconnected to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at different concentrations (e.g., via a gas mixer), duration of use, and flows. It will connect to an oxygen source and will typically include a flowmeter or flow controlling device, masks, tubing, valves, and/or nasal cannulae. It can also include, e.g., a high pressure gas reduction valve(s) and a pneumatically-powered suction device with collection bottle. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B005003250 | HIBCC |
Customer Contacts
- Phone
- (760) 744-6561
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K921926 | 000 |