FDA.report

AincA®

Primary DI
B005004100
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
00-410
Catalog number
00-410
Device description
Adapter, Respirometer, 23mmF x 15mmF, Aluminum
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

Related Records

Product Codes

CodeName
BZACONNECTOR, AIRWAY (EXTENSION)

Product Code Classifications

CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B005004100PrimaryHIBCC0

GMDN Terms

TermDefinition
Low-pressure tubing connector, reusableA device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(760)744-6561Solutions@AincA.com

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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