AccessGUDID - DEVICE: Merlin (10884527006120)

GUDID

Device Identifier (DI) Information

Brand Name: Merlin
Version or Model: 606130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 606130
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527006120
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Prep Applicator, Alcohol Free,PVP-I

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?
35567	Surgical personnel scrub preparation kit	A collection of devices designed for preoperative preparation of surgical personnel, e.g., scrubbing the fingers, hands and forearms, prior to gloving and donning surgical apparel. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEC	BRUSH, SCRUB, OPERATING-ROOM

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: Keep Dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 39 Milliliter

Device Record Status

Public Device Record Key: ded041df-eb69-4520-89a5-e410476647a7
Public Version Date: November 19, 2020
Public Version Number: 3
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
20884527006127	20	10884527006120		In Commercial Distribution	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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES