Dimension® AHDL CAL - AHDL Calibrator, 2x3x1mL - Siemens Healthcare Diagnostics Inc.

Duns Number:005088112

Device Description: AHDL Calibrator, 2x3x1mL

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More Product Details

Catalog Number

DC48B

Brand Name

Dimension® AHDL CAL

Version/Model Number

10464328

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K983850

Product Code Details

Product Code

JIT

Product Code Name

CALIBRATOR, SECONDARY

Device Record Status

Public Device Record Key

2d12b650-acf7-4cf7-8ea2-73e18f8dcf9e

Public Version Date

March 08, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIEMENS HEALTHCARE DIAGNOSTICS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 363
2 A medical device with a moderate to high risk that requires special controls. 829
3 A medical device with high risk that requires premarket approval 57
U Unclassified 7