AccessGUDID - DEVICE: Dimension/Vista Lipase Calibrator (00630414292755)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension/Vista Lipase Calibrator
Version or Model: 11538127
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DC56B
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414292755
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Dimension/Vista Lipase Calibrator

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?
53109	Lipase IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of lipase in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIT	Calibrator, secondary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e0ea474b-f373-4254-a428-5677d46530af
Public Version Date: March 16, 2023
Public Version Number: 3
DI Record Publish Date: November 05, 2021