AccessGUDID - DEVICE: McKesson (00612479226951)

GUDID

Device Identifier (DI) Information

Brand Name: McKesson
Version or Model: 176-5728
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MCKESSON MEDICAL-SURGICAL INC.

Primary DI Number: 00612479226951
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 023904428 *Terms of Use

Device Description: Skin Barrier Film 2.4 in x 2.4 in

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):	No
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?
62524	Ostomy leak absorbent pad	A non-sterile absorbent device intended to be fitted around the connection between an ostomy base plate and an ostomy bag, to absorb any sweat or bodily fluid/waste associated with a leak between the base plate and the skin, to prevent its spread, absorption by clothing, and to reduce skin irritation. It is a flat pad made from a suitably absorbent material with a hole for installation. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NEC	Bandage, Liquid, Skin Protectant

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: b6b3aa93-8832-42a8-98e1-aa88e82f0bf2
Public Version Date: April 12, 2019
Public Version Number: 1
DI Record Publish Date: April 04, 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
00612479228283	100	00612479226951		In Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00612479240216 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

[?]

No Customer Contact currently defined

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