V.A.C. VERAT.R.A.C. DUO™

GUDID 00849554001312

VAC Veralink Cassette

KCI USA, INC.

Negative-pressure wound therapy tubing set Negative-pressure wound therapy tubing set Negative-pressure wound therapy tubing set Negative-pressure wound therapy tubing set Negative-pressure wound therapy tubing set Negative-pressure wound therapy tubing set Negative-pressure wound therapy tubing set Negative-pressure wound therapy tubing set Negative-pressure wound therapy tubing set Negative-pressure wound therapy tubing set Negative-pressure wound therapy tubing set Negative-pressure wound therapy tubing set Negative-pressure wound therapy tubing set Negative-pressure wound therapy tubing set
Primary Device ID00849554001312
NIH Device Record Keyd15d1e34-24f1-491e-8c38-8cbe4b8590da
Commercial Distribution StatusIn Commercial Distribution
Brand NameV.A.C. VERAT.R.A.C. DUO™
Version Model NumberULTLNK0500
Company DUNS102726734
Company NameKCI USA, 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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100849554000186 [Package]
Package: 5 PACK [5 Units]
In Commercial Distribution
GS100849554001312 [Primary]
GS100849554003231 [Package]
Package: 5 PACK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMPNegative Pressure Wound Therapy Powered Suction Pump

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-08-22
Device Publish Date2016-09-05

On-Brand Devices [V.A.C. VERAT.R.A.C. DUO™ ]

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00849554001329Vac Veraflo Cleanse Dressing System
00849554001312VAC Veralink Cassette

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