AccessGUDID - DEVICE: Hollister (00610075093458)

GUDID

Device Identifier (DI) Information

Brand Name: Hollister
Version or Model: 9345
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9345
Company Name: HOLLISTER INCORPORATED

Primary DI Number: 00610075093458
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 005527098 *Terms of Use

Device Description: Extension Tubing with connector

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
65173	Urine drainage extension tubing	A length of noninvasive flexible tubing intended to connect between a patient contact urinary drainage device (e.g., urethral catheter, urostomy pouch) and a receptacle; some types may in addition be intended for extra-urinary passive drainage applications (e.g., intestinal ostomy or wound drainage). It is typically self-applied; it does not include a valve or clamp (i.e., not a tubing set). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NNZ	SYSTEM, URINE DRAINAGE, CLOSED, FOR NON-INDWELLING CATHETER, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 46 Centimeter

Device Record Status

Public Device Record Key: 75615004-168f-4ff9-ad0a-03cb64a74de0
Public Version Date: August 25, 2023
Public Version Number: 2
DI Record Publish Date: December 01, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20610075093452	4	00610075093458		In Commercial Distribution	CAS

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00610075151202 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: +1(800)323-4060
Email: cs@hollister.com

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