AccessGUDID - DEVICE: Dimension Vista® Aliquot Plates (00842768016264)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista® Aliquot Plates
Version or Model: 10445210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KS840
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768016264
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Aliquot Plates, 30x12 (360)

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?
47775	General specimen container IVD, no additive/medium	An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. 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: 9d68f0e4-2c51-445d-8f46-7c0b2d6c5af4
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2020