AccessGUDID - DEVICE: Dover (10192253051407)

GUDID

Device Identifier (DI) Information

Brand Name: Dover
Version or Model: 2040SA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2040SA
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10192253051407
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Dover Midstream Specimen Catch Kit with Funnel, Castile Soap Towelettes 2 oz (59 mL)

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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
Storage Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Fluid Ounce

Device Record Status

Public Device Record Key: b056cdf6-f62b-4bfa-8126-2b50a2dc41c1
Public Version Date: August 28, 2024
Public Version Number: 1
DI Record Publish Date: August 20, 2024