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AincA

FDA UDI

Class II (US FDA UDI)

by Anesthesia Associates, Inc.

Identity

Trade Name
AincA FDA UDI
Generic Name
Mechanical expiratory valve, reusable FDA UDI
Device Name
Adapter, Mask Elbow, CPAP w/Adj Pop-Off, 15mmM x 22mmM/15mmF x 1/4"O2 x 1/4"Sensor, Chrome Brass FDA UDI
Model / Reference
00-488 FDA UDI
Description
Adapter, Mask Elbow, CPAP w/Adj Pop-Off, 15mmM x 22mmM/15mmF x 1/4"O2 x 1/4"Sensor, Chrome Brass FDA UDI

Identifiers

Catalog Number
00-488 FDA UDI
Primary DI / UDI-DI
B005004880 FDA UDI
FDA Product Code
BYE FDA UDI
GMDN Term
Mechanical expiratory valve, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5965 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Mechanical expiratory valve, reusable

AincA by Anesthesia Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical expiratory valve, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anesthesia Associates, Inc.

Sources (1)

  • FDA UDI e08f0ca9-f2a0-44d5-8c73-0956c21fbd74 35 fields · synced May 31, 2026