FDA.reportPublic FDA data

IV START KIT

Primary DI
M57257028311
Brand
IV START KIT
Company
STRADIS MEDICAL LLC
Model
570-2831
Device description
PREP AREA FOR A NEW OR REPLACEMENT IV
Published
2022-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFXGeneral Purpose Dental Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFXGeneral Purpose Dental TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M57257028311PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Peripherally-inserted central venous catheterA thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043537671
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956453265CARDINAL HEALTHCardinal Health 200, LLCOFX2026-07-06
10198956502895CARDINAL HEALTHCardinal Health 200, LLCOFX2026-06-23
10198956464223CARDINAL HEALTHCardinal Health 200, LLCOFX2026-06-05
08720892104809Crown Cassette 200Rademaker Medical Instruments B.V.OFX2026-06-04
08720892104823Crown Cassette 100Rademaker Medical Instruments B.V.OFX2026-06-04
08720892104847Crown Cassette 300Rademaker Medical Instruments B.V.OFX2026-06-04
08720892104861Crown Cassette 400Rademaker Medical Instruments B.V.OFX2026-06-04
10198956480858CARDINAL HEALTHCardinal Health 200, LLCOFX2026-06-01
10195327485092Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327587352Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327587444Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327593520Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327608170Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327628604Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327654252Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327671099Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327671136Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327674175Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-04-07
10195327640170Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-03-03
10195327643713Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-03-03
10195327640408Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-02-25
10195327641399Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-02-25
10195327619978Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-02-11
10195327588168Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-01-07
10195327592608Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-01-07
10195327582005Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2023-12-31
10195327580599Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2023-12-24
10195327467067Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2023-12-21
10195327469184Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2023-12-21
10195327469306Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2023-12-21