3C Patch® Kit

GUDID 05714188505046

Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially available), Skin Preparation Alcohol Swab (commercially available), Post-Sampling Adhesive Bandage (band aid) (commercially available), and Primary Wound Cover Dressing (commercially available).

Reapplix ApS

Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration
Primary Device ID05714188505046
NIH Device Record Key8f265d53-ca4d-4ef8-86be-bce2b97c5b6d
Commercial Distribution StatusIn Commercial Distribution
Brand Name3C Patch® Kit
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
GS105714188505046 [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 Date2018-07-19

On-Brand Devices [3C Patch® Kit]

05714188505046Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially
05714188505008Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially

Trademark Results [3C Patch]

Mark Image

Registration | Serial
Company
Trademark
Application Date
3C PATCH
3C PATCH
86959370 not registered Live/Pending
Reapplix ApS
2016-03-31
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