DEVICE: Resp-O2 Comfort-Foam Trach Tube Holder,2 PC Neonatal & Infant,Maximum Neck (00840117319257)

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Device Record History
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Device Identifier (DI) Information
Resp-O2 Comfort-Foam Trach Tube Holder,2 PC Neonatal & Infant,Maximum Neck
35027
In Commercial Distribution

Dynarex Corporation
00840117319257
GS1

1
008124539 *Terms of Use
Size 9"/23 cm, Small
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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?
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

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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 Record Status
20909388-9810-4fae-83c9-8cf7aa7a7c56
October 09, 2024
3
May 14, 2022
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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
00840117319097 10 00840117319257 In Commercial Distribution Box
00840117319172 5 00840117319097 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
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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