AccessGUDID - DEVICE: ChemoPlus (10884527004355)

GUDID

Device Identifier (DI) Information

Brand Name: ChemoPlus
Version or Model: CT0014
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CT0014
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527004355
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 300
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Low Lint Towel

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):	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?
17803	Infectious waste absorbent	A chemical product intended to be used to treat infectious fluids (e.g., blood, vomit, or urine) that contaminate a site. It is provided in liquid (spray), powder, or granulated form, and it typically absorbs, encapsulates, and disinfects the waste to render it harmless. The liquid waste is typically solidified as a final product and can thereafter be treated as ordinary waste. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRL	FIBER, MEDICAL, ABSORBENT

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: ;

Clinically Relevant Size

[?]

Size Type Text
Width: 9 Inch
Length: 9 Inch

Device Record Status

Public Device Record Key: c679a487-fb03-49b0-9c93-e71a4fcff015
Public Version Date: February 15, 2019
Public Version Number: 2
DI Record Publish Date: June 30, 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
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 20884527004352 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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