DEVICE: Venti.Plus (04710810100277)

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Device Record History
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Device Identifier (DI) Information
Venti.Plus
5406
In Commercial Distribution
H050-HD1
GaleMed Xiamen Co., Ltd.
04710810100277
GS1

1
527333326 *Terms of Use
0.5 HYPERINFLATION W/ MANMTR, MASK
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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
NHK Resuscitator,Manual,Non Self-Inflating
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K092687 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between -30 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
7e4c4dcb-988c-4899-b975-cecaf026fff6
October 24, 2022
5
September 19, 2015
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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
44710810100275 10 04710810100277 In Commercial Distribution Carton
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Secondary DI

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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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