Covidien DVT Sleeve

GUDID 10861317020078

Kendall SCD Express Thigh Medium

RENU MEDICAL, INC

Multi-chamber venous compression system garment, reprocessed
Primary Device ID10861317020078
NIH Device Record Key2a9f60b7-021d-4eee-ae61-b442c9a072dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCovidien DVT Sleeve
Version Model NumberRM-9530
Company DUNS100439103
Company NameRENU MEDICAL, INC
Device Count1
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100861317020071 [Primary]
GS110861317020078 [Package]
Contains: 00861317020071
Package: CASE [5 Units]
In Commercial Distribution

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 Date2016-08-23

On-Brand Devices [Covidien DVT Sleeve]

00861317023232Kendall SCD - Lg Knee pr
10861317023086Kendall SCD - Small Thigh pr
00861317023072Kendall SCD - Medium Thigh pr
10861317022911Kendall SCD Express Thigh Small
10861317022904Kendall SCD Express Foot/Lg
00861317022891Kendall SCD Express Foot/Reg
10861317022881Kendall SCD - Knee Length pr
10861317020092Kendall SCD Express Knee/Lg
10861317020085Kendall SCD Express Thigh Lg
10861317020078Kendall SCD Express Thigh Medium
10861317020061Kendall SCD Express Knee/Med
10861317020054Kendall ImPad Rigid Sole Foot Covers Lg. Pair
10861317020047Kendall Impad Rigid Sole Foot Covers Reg. Pair
00816317023232Kendall SCD - Lg Knee pr
10816317023086Kendall SCD - Small Thigh pr
00816317023072Kendall SCD - Medium Thigh pr
10816317022911Kendall SCD Express Thigh Small
10816317022904Kendall SCD Express Foot/Lg
00816317022891Kendall SCD Express Foot/Reg
10816317022881Kendall SCD - Knee Length pr
10816317020092Kendall SCD Express Knee/Lg
10816317020085Kendall SCD Express Thigh Lg
10816317020078Kendall SCD Express Thigh Medium
10816317020061Kendall SCD Express Knee/Med
10816317020054Kendall ImPad Rigid Sole Foot Covers Lg. Pair

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