AccessGUDID - DEVICE: McKesson (10612479208992)

GUDID

Device Identifier (DI) Information

Brand Name: McKesson
Version or Model: 989
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MCKESSON MEDICAL-SURGICAL INC.

Primary DI Number: 10612479208992
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 023904428 *Terms of Use

Device Description: Lemon Glycerin Swabsticks (3’s) ORAL | PREMOISTENED | STERILE

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?
46466	Skin degreaser	A solvent material (e.g., liquid trichloroethane or trifluoroethane) used on the skin to dissolve surface skin oil, typically in preparation for surgery. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXG	Applicator, Absorbent Tipped, Sterile

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: a34b0c6d-5a4c-42bf-a80e-19fd55f2a522
Public Version Date: July 23, 2020
Public Version Number: 1
DI Record Publish Date: July 15, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20612479209002	25	10612479208992		In Commercial Distribution	Box
40612479209013	10	20612479209002		In Commercial Distribution	Case

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00612479236752 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

[?]

No Customer Contact currently defined

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