DEVICE: Vital Signs™ (10889483601693)

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Device Record History
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Device Identifier (DI) Information
Vital Signs™
M1019515
In Commercial Distribution
M1019515
AirLife Finland Oy
10889483601693
GS1

1
368457563 *Terms of Use
10190752136120
Vital Signs™ Breathing Circuit, Adult, Expandable, Disposable, 3.0 m/120in With Gas Sampling Elbow, Anesthesia Gas Sampling line (3 m/ 10 ft.) and Manual Bag, 3 L
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
837dfa2d-1052-48a3-898d-7c46a2d3e97e
April 07, 2025
1
March 28, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20889483601690 20 10889483601693 In Commercial Distribution Case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
(800)433-2797
info@sun-med.com
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