AccessGUDID - DEVICE: TRACOE® care (04035324059911)

GUDID

Device Identifier (DI) Information

Brand Name: TRACOE® care
Version or Model: REF 935
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tracoe medical GmbH

Primary DI Number: 04035324059911
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 319414785 *Terms of Use

Device Description: TRACOE tube clean Cleaning swabs small

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
For Single-Use:	Yes
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?
58718	Tracheostomy tube cannula cleaning swab, non-sterile	A non-sterile device intended to be used to clean the inner cannula of a tracheostomy tube that has been removed from the in situ tracheostomy tube. It typically consists of a flexible shaft, which in itself can act as a handle, with a swab made of foam or bristles at the distal end. It is used by a patient or healthcare provider to remove secretions from the inside of the inner cannula. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KXF	APPLICATOR, ABSORBENT TIPPED, NON-STERILE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: no special storage conditions

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Overall length: 150 mm Diameter of sponge: 4.5 mm

Device Record Status

Public Device Record Key: bd2f0fef-558b-4206-88aa-82ae8a2d2ab2
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: March 15, 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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +49613691690
Email: info@tracoe.com

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