DEVICE: HUDSON RCI (04026704391417)

Device Identifier (DI) Information

HUDSON RCI
IPN044347
In Commercial Distribution
403133
TELEFLEX INCORPORATED
04026704391417
GS1

1
002348191 *Terms of Use
ADAPTOR,033 NEB,INTL
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Device Characteristics

MR Unsafe
No
Yes
Yes
No
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?
61167 Nebulizing adaptor
A non-powered small connecting device, which includes an integrated nebulizer, intended to join a sterile water or sterile isotonic sodium chloride solution reservoir to a respiratory gas source (typically wall outlet) and a gas administration device (e.g., mask, mouthpiece). It is designed to generate aerosolized fluid (finely dispersed airborne droplets in a liquid phase) to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAF NEBULIZER (DIRECT PATIENT INTERFACE)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K153010 000
No CLOSE

Sterilization

Yes
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

29584cd9-7eb7-4a13-950f-e4b9ea2755bd
June 10, 2022
6
September 16, 2016
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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
24026704391411 50 04026704391417 2019-09-30 Not in Commercial Distribution Box
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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
Yes
No
No CLOSE

Customer Contact

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