AccessGUDID - DEVICE: McKesson (00612479240155)

GUDID

Device Identifier (DI) Information

Brand Name: McKesson
Version or Model: 37-6281
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MCKESSON MEDICAL-SURGICAL INC.

Primary DI Number: 00612479240155
Issuing Agency: GS1
Commercial Distribution End Date: August 18, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 023904428 *Terms of Use

Device Description: Normal Saline

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):	Yes
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?
63285	Multi-purpose therapeutic saline solution	A water-based salt solution (e.g., sodium chloride isotonic solution) intended for alternative use in multiple patient applications including inhalation therapy, moisturizing and washing/irrigation of the eyes, nose and ears, and wound cleansing; it is not dedicated to a specific application or part of the anatomy. It is typically available in a squeeze bottle for self-administration or application to infants for preventive or symptomatic care in the home. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083042	000

Device Exempt from Premarket Submission: No 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: c534977f-45ce-4f5b-a218-ae04cc7fc758
Public Version Date: February 05, 2024
Public Version Number: 4
DI Record Publish Date: May 12, 2021