FDA.reportPublic FDA data

Stradis Medical, LLC

Primary DI
M752TMCLK15
Brand
Stradis Medical, LLC
Company
STRADIS MEDICAL LLC
Model
TMCLK-1
Device description
Central Line Kit
Published
2019-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M752TMCLK15PackageHIBCC30In Commercial Distribution
M752TMCLK10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheterization support/maintenance kit, non-medicatedA collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-424-8520cs@stradishealthcare.com

Regulatory Flags#

DUNS number
043537671
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M752CPD20000Stradis Medical, LLCCPD-20002020-04-14
M752ACC26001Stradis Medical, LLC.ACC-26002019-09-24
M752DC1790920Stradis Medical, LLC.DC-17909-22020-06-10
M752HCT200GD20Stradis Medical, LLC.HCT200GD-22020-07-16
M752HCT6186CP10Stradis Medical, LLCHCT6186CP-12020-07-02
M752HCT8874VA20Stradis Medical, LLC.HCT8874VA-22019-10-08
M752HCT900AGD10Stradis Medical, LLC.HCT900AGD-12020-07-23
M752TM85161Stradis Medical, LLC.TM85162019-09-06
M752TM85170Stradis Medical, LLC.TM.85172021-03-05
M752TM882310Stradis Medical, LLCTM8823-12019-06-21
M752TM882311Stradis Medical, LLCTM8823-12019-07-22
M752TMCLK10Stradis Medical, LLCTMCLK-12019-12-23
M752TMCLK20Stradis Medical, LLCTMCLK-22021-04-13
M752HCT900CHX0ARTERIAL LINE DRESSING CHANGE KITHCT900CHX2022-01-10
M752HCT6625CTA0Stradis Medical, LLC.HCT6625TC-A2020-07-13
M752HCT100GD20Stradis Medical, LLCHCT100GD-22020-07-16
M752TN170313069C0Stradis Medical, LLCTN1703-13069C2020-06-16
M752TSBRF6640Stradis Medical, LLCTSBRF-6642020-10-26
M752TSBRF6630Stradis Medical, LLCTSBRF-6632020-10-26
M752HCT8249CP3A0Stradis Medical, LLC.HCT8249CP-3A2020-11-03