Venipuncture Needle and 3C Patch® Needle Holder - Extra Component Set

GUDID 05714188505220

This is the outer label for the box that contains 20 venipuncture needle sets (commercially available), 20 3C Patch Needle Holder, and the IFU.

Reapplix ApS

Haematological concentrate system preparation kit, platelet concentration
Primary Device ID05714188505220
NIH Device Record Key417762e9-1500-4425-a69c-20e036ae9d2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenipuncture Needle and 3C Patch® Needle Holder - Extra Component Set
Version Model Number1
Company DUNS312293991
Company NameReapplix ApS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com
Phone+4588168066
Emailinfo@reapplix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105714188505220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PMQPeripheral Blood Processing Device For Wound Management

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-09
Device Publish Date2019-01-09

On-Brand Devices [Venipuncture Needle and 3C Patch® Needle Holder - Extra Component Set]

05714188505220This is the outer label for the box that contains 20 venipuncture needle sets (commercially avai
05714188505206This is the outer label for the box that contains 20 venipuncture needle sets (commercially avai

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