Flowtron Tri Pulse

GUDID 15055982700839

DVT Prevention Compression Garment - TRP30 CALF/THIGH

Arjohuntleigh AB

Intermittent venous compression system
Primary Device ID15055982700839
NIH Device Record Key0f8bd8db-a55e-4a4b-ac57-8d5a4dd80051
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlowtron Tri Pulse
Version Model NumberTRP30
Company DUNS355804758
Company NameArjohuntleigh AB
Device Count10
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800) 323-1245
Emailus.info@arjo.com
Phone1(800) 323-1245
Emailus.info@arjo.com
Phone1(800) 323-1245
Emailus.info@arjo.com
Phone1(800) 323-1245
Emailus.info@arjo.com
Phone1(800) 323-1245
Emailus.info@arjo.com
Phone1(800) 323-1245
Emailus.info@arjo.com
Phone1(800) 323-1245
Emailus.info@arjo.com
Phone1(800) 323-1245
Emailus.info@arjo.com
Phone1(800) 323-1245
Emailus.info@arjo.com
Phone1(800) 323-1245
Emailus.info@arjo.com
Phone1(800) 323-1245
Emailus.info@arjo.com
Phone1(800) 323-1245
Emailus.info@arjo.com
Phone1(800) 323-1245
Emailus.info@arjo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055982700832 [Unit of Use]
GS115055982700839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSLEEVE, LIMB, COMPRESSIBLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [Flowtron Tri Pulse]

15055982700853DVT Prevention Compression Garment - TRP60L BARIATRIC CALF/THIGH
15055982700846DVT Prevention Compression Garment - TRP40 LARGE CALF/THIGH
15055982700839DVT Prevention Compression Garment - TRP30 CALF/THIGH
15055982700822DVT Prevention Compression Garment - TRP20 GARMENT LARGE CALF
15055982700815DVT Prevention Compression Garment - TRP10 GARMENT CALF

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.