AccessGUDID - DEVICE: CATH-SECURE for Kids (00048329000035)

GUDID

Device Identifier (DI) Information

Brand Name: CATH-SECURE for Kids
Version or Model: 7334-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: M.C. JOHNSON CO., INC.

Primary DI Number: 00048329000035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 112853395 *Terms of Use

Device Description: Pediatric Urological Securement Device

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):	No
Over the Counter (OTC):	Yes
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?
57982	Urinary catheter holder	A device designed to be attached to a patient's body to hold an indwelling urinary catheter line (e.g., Foley) in place. It consists of a wrap or adhesive strip/pad placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook, loop, clip) without creating excessive pressure on it and permitting visual inspection of the site. It is not designed to hold a urine collection bag. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EYJ	Holder, 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: 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
No Device Sizes

Device Record Status

Public Device Record Key: e9ed7758-ec36-4f4b-a97b-992ed2a94b44
Public Version Date: June 17, 2021
Public Version Number: 1
DI Record Publish Date: June 09, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10048329000032	50	00048329000035		In Commercial Distribution	INNER CARTON
20048329000039	8	10048329000032		In Commercial Distribution	MASTER SHIP CASE

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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 2394331538
Email: charlis@mcjohnson.com

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