DEVICE: PEDIATRIC ULTRA FLEX®ANESTHESIA BREATHING CIRCUIT (00612649199887)
Device Identifier (DI) Information
PEDIATRIC ULTRA FLEX®ANESTHESIA BREATHING CIRCUIT
AJ21216P-132
Not in Commercial Distribution
AJ21216P-132
King Systems Corporation
AJ21216P-132
Not in Commercial Distribution
AJ21216P-132
King Systems Corporation
PEDIATRIC ULTRAFLEX CIRCUIT
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
37704 | Anaesthesia breathing circuit, single-use |
An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAI | Circuit, breathing (w connector, adaptor, y piece) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Pediatric |
Device Record Status
a211abae-1064-4b10-bdeb-5acef5d5e46c
October 24, 2022
6
September 22, 2016
October 24, 2022
6
September 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00612649170640 | 20 | 00612649199887 | 2021-10-08 | Not in Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+14107686464
Purchase_orders@ambuUSA.com
Purchase_orders@ambuUSA.com