AccessGUDID - DEVICE: Precision (10884527004928)

GUDID

Device Identifier (DI) Information

Brand Name: Precision
Version or Model: 2300SA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2300SA
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527004928
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 200
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Specimen Container,Positive Seal Indicator

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):	No
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?
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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Height: 2.75 Inch
Width: 2.5 Inch
Total Volume: 4 Fluid Ounce

Device Record Status

Public Device Record Key: 147a1873-7fc9-4a83-a2a4-087cce05e815
Public Version Date: September 01, 2023
Public Version Number: 3
DI Record Publish Date: June 29, 2018