FDA.report

AincA®

Primary DI
B005AAS1109130
Brand
AincA®
Company
ANESTHESIA ASSOCIATES, INC.
Model
AAS-11091-3
Catalog number
AAS-11091-3
Device description
Breathing Tube, 22mmM x 22mmF, Polyester/Silicone/SS, 48-inch. (Substitute for GEHealthcare# 1101-3026-000)
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
CAICircuit, breathing (w connector, adaptor, y piece)

Product Code Classifications

CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B005AAS1109130PrimaryHIBCC0

GMDN Terms

TermDefinition
Tube/mask breathing circuit connector, reusableA device intended to connect a breathing circuit breathing tube to an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It may be made of plastic and/or metal and can have a straight or elbow-shaped design (excluding Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. 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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