AccessGUDID - DEVICE: Kendall (10884527005604)

GUDID

Device Identifier (DI) Information

Brand Name: Kendall
Version or Model: 8889207034
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8889207034
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527005604
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 500
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Specimen Container with White Screw Top Lid

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):	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?
12542	Midstream urine specimen container IVD	A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of first-voided urine is diverted to a separate reservoir for discarding. Additional items may be included (e.g., towelettes). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMH	CONTAINER, SPECIMEN, 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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: ;

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Total Volume,4,OZ;

Device Record Status

Public Device Record Key: c3a074fd-659d-4371-a702-29e62b805715
Public Version Date: September 27, 2024
Public Version Number: 3
DI Record Publish Date: June 27, 2018