AccessGUDID - DEVICE: Dimension® ACP Verifier (00842768005039)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® ACP Verifier
Version or Model: 10444994
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DC23
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768005039
Issuing Agency: GS1
Commercial Distribution End Date: January 25, 2023
Device Count: 6
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Acid Phosphatase Verifier, 2x3x1mL, volume after reconstituted

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):	Yes
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?
45785	Acid phosphatase isoenzyme IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple acid phosphatase isoenzymes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CKE	Acid phosphatase, thymolphthale inmonophosphate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K864230	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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: de6efcfb-5130-4c81-b5ab-8971b4beacab
Public Version Date: January 09, 2024
Public Version Number: 17
DI Record Publish Date: September 24, 2016