AccessGUDID - DEVICE: UA-Cellular for UF (00844509001997)

GUDID

Device Identifier (DI) Information

Brand Name: UA-Cellular for UF
Version or Model: 213465
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 213465
Company Name: STRECK, INC.

Primary DI Number: 00844509001997
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 072915986 *Terms of Use

Device Description: Urinalysis control designed specifically for the Sysmex® UF-1000i™ urine analyzer. Contains 1 vial each of Level 1 & 2.

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
42065	Urine sediment IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or semi-quantitative screening of urine sediment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JPK	Mixture, Hematology Quality Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090201	000

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
Storage Environment Temperature: between 2 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 45 Milliliter

Device Record Status

Public Device Record Key: 33a0759a-df08-4681-985e-520da45a9b96
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 19, 2016