AccessGUDID - DEVICE: McKesson (20612479195558)

GUDID

Device Identifier (DI) Information

Brand Name: McKesson
Version or Model: 2167
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MCKESSON MEDICAL-SURGICAL INC.

Primary DI Number: 20612479195558
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2017
Device Count: 50
Labeler D-U-N-S® Number*: 023904428 *Terms of Use

Device Description: Blood Collection Set 25G

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):	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?
17825	Scalp vein intravenous administration set	A collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container into a patient's scalp vein. It typically includes tubing, connectors, chambers, clamps, and specialized needles to access scalp veins. The device is normally intended for use on paediatric patients, especially infants. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FOZ	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953252	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: 1f6d8f29-a450-4bcb-8d0f-f09ec9008017
Public Version Date: November 29, 2018
Public Version Number: 4
DI Record Publish Date: June 29, 2017