AccessGUDID - DEVICE: Dimension Vista Barcode Labels (00842768024719)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista Barcode Labels
Version or Model: 10464353
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KS866
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768024719
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Dimension Vista Barcode Labels

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?
63375	Printer label IVD	A thin, blank sheet of fibrous material, typically with an adhesive underside, intended to be imprinted with an image/text using a printer, and then applied to an object for identification (e.g., barcode) or information associated with an in vitro diagnostic procedure. It is typically available as a continuous roll with individual labels arranged on a waxy backing sheet for easy peeling. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2f69a4ca-cce2-4481-ac79-61a7dd38acd9
Public Version Date: January 19, 2022
Public Version Number: 3
DI Record Publish Date: November 13, 2020