AccessGUDID - DEVICE: Dimension Vista® Flex® reagent cartridge EMPTY (00842768015656)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista® Flex® reagent cartridge EMPTY
Version or Model: 10445218
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KS999
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768015656
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: EMPTY Flex® reagent cartridge, 4 Flex® reagent cartridges

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:	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?
62225	Assay container IVD, single-use	A reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051087	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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 38ffb9ef-5f03-4a80-b68c-1ad3c1e351f1
Public Version Date: November 18, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2020