DEVICE: TRACOE® sensitive (04035324020201)

Device Identifier (DI) Information

TRACOE® sensitive
REF 721
In Commercial Distribution

Tracoe medical GmbH
04035324020201
GS1

1
319414785 *Terms of Use
cuff pressure monitor sensitive
CLOSE

Device Characteristics

MR Unsafe
No
Yes
No
Yes
No
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
Endotracheal tube cuff inflator A device designed to instill air into the cuff of an in situ endotracheal (ET)/endobronchial tube. The inflator typically includes a manually-operated rubber bulb for the delivery of ambient air into the cuff, and a pressure gauge or manometer that displays the pressure within the cuff to help prevent the development of excessive pressure which may cause trauma to the trachea. The purpose of the cuff is to provide an adequate seal for positive pressure ventilation and to prevent aspirated secretions from passing into the lungs. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
BSK Cuff, tracheal tube, inflatable
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Protect from heat and store in a dry place, keep away from sunlight and light sources, Store and transport in the original packaging
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 0-120 cmH2O
CLOSE

Device Record Status

f631863a-b88c-468e-8f73-d9a8c9aa10fe
March 29, 2018
2
June 30, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+49613691690
info@tracoe.com
CLOSE