Low Titer Type O Donor Collection Set - LOW TITER TYPE O DONOR COLLECTION SETConstricting - Safeguard US Operating, LLC

Duns Number:118492643

Device Description: LOW TITER TYPE O DONOR COLLECTION SETConstricting Band (18"x1") 1 eaSafety IV Catheter 16 LOW TITER TYPE O DONOR COLLECTION SETConstricting Band (18"x1") 1 eaSafety IV Catheter 16gx1.25" 2 eaTransparent Film Dressing 2 eaChlorhexidine Swap 4 eaBlood Collection Bag 1 eaBeaded Cable Tie 1eaNeedle-Free Valve with Luer Lock 2 eaDD Form 572 1 ea

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More Product Details

Catalog Number

80-875-D

Brand Name

Low Titer Type O Donor Collection Set

Version/Model Number

02

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2021

Issuing Agency

In HIBCC

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

-

Product Code Details

Product Code

BRZ

Product Code Name

Set, Blood Transfusion

Device Record Status

Public Device Record Key

01bbb1ff-f92d-496c-8dc1-5d539c38c9b8

Public Version Date

April 12, 2022

Public Version Number

5

DI Record Publish Date

September 18, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFEGUARD US OPERATING, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 217
2 A medical device with a moderate to high risk that requires special controls. 48