CTC

GUDID 30817357021531

CTC VasoPress Calf Garment Medium - For calf sizes up to 18 inches

HYGIA HEALTH SERVICES, INC.

Single-chamber venous compression system garment, reprocessed
Primary Device ID30817357021531
NIH Device Record Key60509556-5cc7-41a2-85da-0d698b47c498
Commercial Distribution Discontinuation2019-07-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCTC
Version Model NumberVP501M
Company DUNS177939027
Company NameHYGIA HEALTH SERVICES, 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110817357021537 [Primary]
GS130817357021531 [Package]
Contains: 10817357021537
Package: Box [10 Units]
Discontinued: 2021-03-19
Not 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 Number4
Public Version Date2021-03-19
Device Publish Date2016-09-24

On-Brand Devices [CTC]

30817357021838CTC VasoPress Calf Garment Large- For calf sizes up to 24 inches
30817357021531CTC VasoPress Calf Garment Medium - For calf sizes up to 18 inches

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