FDA UDI
In Commercial Distribution
🇺🇸 United States
AincA
DI: B005002290
·
Model: 00-229
·
ANESTHESIA ASSOCIATES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AincA
- Primary DI
- B005002290
- Version / Model
- 00-229
- Catalog Number
- 00-229
- 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
- 3
- Public Version Date
- 2020-09-25
- Public Version Status
- Update
- Public Device Record Key
- fe77b767-2d89-4e52-8d18-5536195ee9a8
Device Description
Adapter, Mask Elbow, CPAP w/Adj Pop-Off, 15mmM x 22mmM/15mmF x 1/4" O2 x 1/4" Sensor, Aluminum
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
- Yes
- 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 |
|---|---|---|---|---|
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | Anesthesiology | 868.5965 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37819 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B005002290 | HIBCC |
Customer Contacts
- Phone
- (760) 744-6561
- [email protected]