AccessGUDID - DEVICE: Urine Monovette® 10ml bor.acid (04038917279918)

GUDID

Device Identifier (DI) Information

Brand Name: Urine Monovette® 10ml bor.acid
Version or Model: 10.253
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10.253
Company Name: Sarstedt Aktiengesellschaft & Co.KG

Primary DI Number: 04038917279918
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 64
Labeler D-U-N-S® Number*: 388000270 *Terms of Use

Device Description: No description.

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?
63348	Non-evacuated urine specimen container IVD, preservative	A covered receptacle containing one or multiple preservatives [e.g., mercuric oxide, boric acid (H3BO3), benzoic acid, potassium phosphate, and/or sodium phosphate] intended to be used for the collection, preservation, and/or transport, of a urine specimen for culture, analysis, and/or other in vitro diagnostic investigation. It may include a disposable pipette to transfer the urine specimen into a secondary container (not included). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSM	CULTURE MEDIA, NON-PROPAGATING TRANSPORT

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
No Device Sizes

Device Record Status

Public Device Record Key: 281b5943-dc64-41cc-85ad-a0a3fae14afd
Public Version Date: August 03, 2023
Public Version Number: 2
DI Record Publish Date: November 30, 2022