AccessGUDID - DEVICE: GU Tek (00850005780168)

GUDID

Device Identifier (DI) Information

Brand Name: GU Tek
Version or Model: UCA5-95
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UCA5-95
Company Name: V L V ASSOCIATES (INC)

Primary DI Number: 00850005780168
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118877356 *Terms of Use

Device Description: Ureteral Catheter Connecting Adapter

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":	Yes
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?
64695	Ureteral/urethral catheter multichannel external connector	A small, non-powered, noninvasive, small-bore, tubular connector, with three or more connections that are non-ISO80369-standardized, intended to connect both a urethral catheter and a ureteral catheter(s) to tubing during a drainage procedure. It does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EYK	Connector, Ureteral Catheter

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d33c617-ca4b-4ff7-9d7a-2267895d3291
Public Version Date: July 23, 2020
Public Version Number: 1
DI Record Publish Date: July 15, 2020

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

[?]

No Customer Contact currently defined

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