AccessGUDID - DEVICE: Urine Monovette®, 10ML with luerlock (04038917075671)

GUDID

Device Identifier (DI) Information

Brand Name: Urine Monovette®, 10ML with luerlock
Version or Model: 10.252.028
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SARSTEDT, INC.

Primary DI Number: 04038917075671
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 035410179 *Terms of Use

Device Description: Urine Monovette®, 10ML with luerlock adapter assembled

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):	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?
46023	Non-evacuated urine specimen container IVD, no additive	A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDT	Container, Specimen Mailer And Storage, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d8a3942a-e0ca-4863-9bbe-de39c345a6dd
Public Version Date: November 30, 2022
Public Version Number: 1
DI Record Publish Date: November 22, 2022