SAFE-T-FILL® - SAFE-T-FILL® MicroHematocrit Capillary Tubes, 50 - RAM SCIENTIFIC, INC

Duns Number:602759672

Device Description: SAFE-T-FILL® MicroHematocrit Capillary Tubes, 50 µL; Plastic, Ammonium Heparinized, Red Ma SAFE-T-FILL® MicroHematocrit Capillary Tubes, 50 µL; Plastic, Ammonium Heparinized, Red Marking

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More Product Details

Catalog Number

06 0507

Brand Name

SAFE-T-FILL®

Version/Model Number

06 0507

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

GHY

Product Code Name

HEMATOCRIT, TUBE, RACK, SEALER, HOLDER

Device Record Status

Public Device Record Key

47963879-c06d-4379-a335-c58c2224286c

Public Version Date

August 09, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

30643351000391

Quantity per Package

10

Contains DI Package

10643351000397

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACKAGE

"RAM SCIENTIFIC, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1