Flexitouch Plus

GUDID 00816305023589

Bilateral Port Adapter (Reconditioned)

TACTILE SYSTEMS TECHNOLOGY, INC.

Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable
Primary Device ID00816305023589
NIH Device Record Key1e32bbc8-dddc-4778-a4a0-d62b85c73207
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexitouch Plus
Version Model NumberR 300050-000-00
Company DUNS146295980
Company NameTACTILE SYSTEMS TECHNOLOGY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816305023589 [Primary]
GS100816305023589 [Primary]
GS100816305023589 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSleeve, Limb, Compressible
JOWSleeve, Limb, Compressible
JOWSleeve, Limb, Compressible

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [Flexitouch Plus]

00816305023572DS 300007-000-00
00816305023565DS 300002-002-00
00816305023558300002-002-00
00816305023541300007-000-00
00816305023534DS 500314-300-00
00816305023527DS 500313-300-00
00816305023510DS 500312-300-00
00816305023503DS 500311-300-00
00816305023497DS 500310-300-00
00816305023480DS 500309-300-00
00816305023473DS 500308-300-00
00816305023466500314-300-00
00816305023459500313-300-00
00816305023442500312-300-00
00816305023435500311-300-00
00816305023428500310-300-00
00816305023411500309-300-00
00816305023404500308-300-00
00816305023398DS 3WX-R
00816305023381R PD32-G3
00816305022896DS 300050-000-00
00816305022889300045-500-00
00816305022872DS 300002-402-00
00816305022858DS 3U-AS-L2-R
00816305022841300002-402-00
00816305022834DS 3WX-L
00816305022827DS 3L-HL-XT-R
00816305022810DS 3L-HL-XT-L
00816305022803DS 3L-TR-XT-R
00816305022797DS 3L-TR-XT-L
00816305022780DS 3A-CH-LG-A
00816305022773DS 3A-CH-MD-A
00816305022766DS 3A-CH-SM-A
00816305022759DS 3A-HD-LG-A
00816305022742DS 3A-HD-MD-A
00816305022735DS 3A-HD-SM-A
00816305022728DS 3U-AS-L4-R
00816305022711DS 3U-AS-L4-L
00816305022704DS 3U-AS-S4-R
00816305022698DS 3U-AS-S4-L
00816305022681DS 3U-AS-L3-R
00816305022674DS 3U-AS-L3-L
00816305022667DS 3U-AS-S3-R
00816305022650DS 3U-AS-S3-L
00816305022636DS 3U-AS-L2-L
00816305022629DS 3U-AS-S2-R
00816305022612DS 3U-AS-S2-L
00816305022605DS 3U-AS-L1-R
00816305022599DS 3U-AS-L1-L
00816305022582DS 3U-AS-S1-R

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.