AccessGUDID - DEVICE: RUSCH (14026704645739)

GUDID

Device Identifier (DI) Information

Brand Name: RUSCH
Version or Model: IPN054584
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 452932
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704645739
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: RUSCH Large Leg Bag With Easy-Tap

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:	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?
58917	Non-wearable adult urine collection bag, closed-ended	A flexible plastic pouch designed to connect to a urinary catheter to collect discharged urine from an adult/adolescent patient; it is not designed with an opening for urine drainage. The device is not directly attached to the patient and is disposed of when full. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAQ	BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, 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: 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: 5a479d17-8ee3-4029-9435-5991e8056045
Public Version Date: January 11, 2024
Public Version Number: 4
DI Record Publish Date: June 20, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
24026704645736	48	14026704645739		In Commercial Distribution	Box

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(919)544-8000
Email: CS@TELEFLEX.COM

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