Mission Capillary Transfer Tubes - Box of 50 capillary transfer tubes (25/bag) - ACON LABORATORIES, INC.

Duns Number:781100966

Device Description: Box of 50 capillary transfer tubes (25/bag)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Mission Capillary Transfer Tubes

Version/Model Number

C121-3081

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K122553,K122553,K122553

Product Code Details

Product Code

GKR

Product Code Name

SYSTEM, HEMOGLOBIN, AUTOMATED

Device Record Status

Public Device Record Key

7fcba730-ac95-4d7d-9b15-6417456d9d4e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20682607200010

Quantity per Package

80

Contains DI Package

00682607200016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"ACON LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
2 A medical device with a moderate to high risk that requires special controls. 6