DEVICE: TRACOE® care (04035324014996)

Device Identifier (DI) Information

TRACOE® care
REF 903-I
In Commercial Distribution

Tracoe medical GmbH
04035324014996
GS1

1
319414785 *Terms of Use
Neck Strap
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Tracheostomy tube neck holder, reusable A 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 reusable device.
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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: no special storage conditions
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: max. length: 48 width: 2.5
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Device Record Status

93d6bcb4-192e-478d-9107-bbe4c504b816
June 11, 2018
3
March 15, 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
No Package DIs found
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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

[?]
+49613691690
info@tracoe.com
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