DEVICE: Hudson RCI (04026704582099)

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Device Identifier (DI) Information

Hudson RCI
IPN045252
8013
TELEFLEX INCORPORATED
04026704582099
GS1
1
ISO-GARD CLEAR AIR MASK, WYE & CLAMPS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Rebreathing oxygen face mask A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is typically non-sterile, non-conductive, and is available in a range of sizes. It is made of high-grade resins and/or other materials that produce a soft, flexible mask that will create an airtight seal against the patient's face. The device may include a headstrap and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
CBN APPARATUS, GAS-SCAVENGING
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 16, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
24026704582093 20 04026704582099 In Commercial Distribution Case
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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(919)544-8000
CS@TELEFLEX.COM
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