AincA®
- Primary DI
- B005003990
- Brand
- AincA®
- Company
- ANESTHESIA ASSOCIATES, INC.
- Model
- 00-399
- Catalog number
- 00-399
- Device description
- Valve, Bloomquist Circle, Adjustable Pop-off, 15mmM Inlet, Chrome Brass
- Published
- 2021-03-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| BYE | Attachment, breathing, positive end expiratory pressure |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | Anesthesiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B005003990 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Mechanical expiratory valve, reusable | A non-sterile mechanical device intended to be used in a respiratory or anaesthesia breathing circuit to maintain a degree of positive pressure in a patient's airway at the end of expiration. Typically constructed of plastic/metal it has a valve that is actuated by a spring to provide expiratory airway resistance, and an adjustable knob (usually not graduated) that is typically set between 0 and 20 cmH20 pressure, but may be fully closed when controlled/assisted ventilation is applied. It is normally used with anaesthesia breathing systems, pulmonary resuscitators, or ventilators and is commonly known as a pop-off valve, relief valve, or spill valve. This is a reusable device. |
Regulatory Flags
- DUNS number
- 002065670
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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| 10841470111592 | Go-PAP | PULMODYNE INC | BYE | 2025-04-12 |
| 10841470111608 | Go-PAP | PULMODYNE INC | BYE | 2025-04-12 |
| 10841470111790 | Go-PAP | PULMODYNE INC | BYE | 2025-04-12 |
| 00850071887013 | Emergent Respiratory | MDL Solutions Incorporated | BYE | 2025-04-05 |
| 00850071887136 | Emergent Respiratory | MDL Solutions Incorporated | BYE | 2025-04-05 |
| 00850071887174 | Emergent Respiratory | MDL Solutions Incorporated | BYE | 2025-04-05 |
| 46923980114340 | N/A | GaleMed Xiamen Co., Ltd. | BYE | 2024-09-11 |
| B00500251DMRI0 | AincA | ANESTHESIA ASSOCIATES, INC. | BYE | 2024-06-18 |
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