AccessGUDID - DEVICE: TRACOE® sensitive (04035324020201)

GUDID

Device Identifier (DI) Information

Brand Name: TRACOE® sensitive
Version or Model: REF 721
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tracoe medical GmbH

Primary DI Number: 04035324020201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 319414785 *Terms of Use

Device Description: cuff pressure monitor sensitive

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35401	Endotracheal tube cuff inflator	A manually-powered 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSK	Cuff, tracheal tube, inflatable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K912723	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 0-120 cmH2O

Device Record Status

Public Device Record Key: f631863a-b88c-468e-8f73-d9a8c9aa10fe
Public Version Date: March 21, 2019
Public Version Number: 4
DI Record Publish Date: June 30, 2016

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

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +49613691690
Email: info@tracoe.com

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