DEVICE: Dr Zee (00850043061069)

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Device Record History
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Device Identifier (DI) Information
Dr Zee
8015
In Commercial Distribution
8015
Resp Devices LLC
00850043061069
GS1

1
104305239 *Terms of Use
Tracheostomy Tube Holders. Two-Piece Wick Foam Collar with Hook and Loop Closure, Neonatal/Infant, 10/bx
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
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?
63438 Tracheostomy tube neck holder, single-use
A non-sterile, noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CBH Device, Fixation, Tracheal Tube
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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
Special Storage Condition, Specify: Keep dry. Keep away from sunlight.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Neonatal/infant. 3/4" Wide, Max neck size 9"/23cm
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Device Record Status
f62aa899-553a-4eee-8cde-524898843dad
November 09, 2022
1
November 01, 2022
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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
10850043061066 10 00850043061069 In Commercial Distribution Box
30850043061060 5 10850043061066 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
No
No CLOSE

Customer Contact

[?]
917-299-1512
respdevices@gmail.com
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