AccessGUDID - DEVICE: OEM CUSTOMER SPECIFIC (50192253051122)

GUDID

Device Identifier (DI) Information

Brand Name: OEM CUSTOMER SPECIFIC
Version or Model: 1270103585
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1270103585
Company Name: Cardinal Health 200, LLC

Primary DI Number: 50192253051122
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5000
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Insert Cups, 16 mm, Beckman Coulter, Inc. Part Number 81917

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):	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?
37566	Blood collection tube holder, single-use	A hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JKA	Tubes, vials, systems, serum separators, blood collection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Height: 16 Millimeter

Device Record Status

Public Device Record Key: 63d33dfa-7d1b-4273-9e3f-617409b18258
Public Version Date: February 05, 2025
Public Version Number: 1
DI Record Publish Date: January 28, 2025