AccessGUDID - DEVICE: Kendall (10884521138896)

GUDID

Device Identifier (DI) Information

Brand Name: Kendall
Version or Model: 6613C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6613C
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521138896
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2023
Device Count: 6
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Standard Porous Tape

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
34832	Waterproof skin adhesive tape	A long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation, intended to be used to cover a surface (e.g., small wound), fix a dressing, attach objects, and/or exert pressure on a body part; it is not hypoallergenic. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape and bandage, adhesive

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: This side up;

Clinically Relevant Size

[?]

Size Type Text
Width: 2 Inch
Device Size Text, specify: Length,10,yard; ;

Device Record Status

Public Device Record Key: 83d06143-1487-471e-8f97-1f9891da56ac
Public Version Date: July 03, 2023
Public Version Number: 5
DI Record Publish Date: June 29, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20884521138893	72	10884521138896	2023-07-01	Not in Commercial Distribution	CASE

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 30884521138890 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)261-8000
Email: covidien.udi@covidien.com

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