FDA UDI
In Commercial Distribution
🇺🇸 United States
AincA®
DI: B005001960
·
Model: 00-196
·
ANESTHESIA ASSOCIATES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AincA®
- Primary DI
- B005001960
- Version / Model
- 00-196
- Catalog Number
- 00-196
- Company Name
- ANESTHESIA ASSOCIATES, INC.
- Labeler DUNS
- 002065670
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-31
- Public Version
- 1
- Public Version Date
- 2021-04-08
- Public Version Status
- New
- Public Device Record Key
- 641fe68f-91cb-4a6b-ae44-97fb577c7c8d
Device Description
Manometer, Wall Mount Swivel Mount, w/Arm (4.5"x180° Rot.) w/Hardware, fits all 00-199, 00-274 Gauges
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
- 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 |
|---|---|---|---|---|
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) | Anesthesiology | 868.2600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46634 | Airway pressure monitor, non-powered | A mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B005001960 | HIBCC |
Customer Contacts
- Phone
- +1(760)744-6561
- [email protected]