Stradis Medical, LLC.

GUDID M752HCT900AGD15

Arterial line Dressing Change Kit - GUARDIVA 4MM

STRADIS MEDICAL LLC

Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit Arterial/central venous catheterization support/maintenance kit
Primary Device IDM752HCT900AGD15
NIH Device Record Key3f5e010e-71f8-40f4-a355-418c5f8e4691
Commercial Distribution StatusIn Commercial Distribution
Brand NameStradis Medical, LLC.
Version Model NumberHCT900AGD-1
Company DUNS043537671
Company NameSTRADIS MEDICAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com
Phone1-800-424-8520
Emailcs@stradishealthcare.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD10 [Primary]
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution
HIBCCM752HCT900AGD15 [Package]
Contains: M752HCT900AGD10
Package: OUTER BOX [30 Units]
In Commercial Distribution

FDA Product Code

PEZCentral Venous Catheter Dressing Change Kit
PEZCentral Venous Catheter Dressing Change Kit
PEZCentral Venous Catheter Dressing Change Kit
PEZCentral Venous Catheter Dressing Change Kit
PEZCentral Venous Catheter Dressing Change Kit
PEZCentral Venous Catheter Dressing Change Kit
PEZCentral Venous Catheter Dressing Change Kit
PEZCentral Venous Catheter Dressing Change Kit
PEZCentral Venous Catheter Dressing Change Kit
PEZCentral Venous Catheter Dressing Change Kit
PEZCentral Venous Catheter Dressing Change Kit
PEZCentral Venous Catheter Dressing Change Kit
PEZCentral Venous Catheter Dressing Change Kit
PEZCentral Venous Catheter Dressing Change Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

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