CELL-DYN - CELL-DYN 3700 SHEATH - ABBOTT LABORATORIES

Duns Number:079226220

Device Description: CELL-DYN 3700 SHEATH

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More Product Details

Catalog Number

9931101

Brand Name

CELL-DYN

Version/Model Number

99311-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2022

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

-

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

-

Product Code Details

Product Code

GGK

Product Code Name

PRODUCTS, RED-CELL LYSING PRODUCTS

Device Record Status

Public Device Record Key

2bd2aa3f-db8f-42f7-91f7-8e34604005be

Public Version Date

June 28, 2022

Public Version Number

3

DI Record Publish Date

June 06, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT LABORATORIES" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 259
2 A medical device with a moderate to high risk that requires special controls. 245
U Unclassified 5