FDA.reportPublic FDA data

Direct IV Solutions - IV Start Kit

Primary DI
00851491007517
Brand
Direct IV Solutions - IV Start Kit
Company
Lynn Medical Instrument Co.
Model
2533-22G
Catalog number
2533-22G
Device description
IV Starter Kit - BD 22G Insyte Catheter, ICU Medical Bravo Connector, 5mm Saline Flush, IV Derm Transparent Silicone, Tourniquet, Gauze, Alcohol Prep Pad, & Under Pad
Published
2020-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRSI.V. Start Kit
OFNWinged Intravenous Catheterization Kit
OJSTourniquet Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRSI.V. Start KitGeneral Hospital2
OFNWinged Intravenous Catheterization KitCardiovascular2
OJSTourniquet KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851491007514PackageGS1100In Commercial Distribution
20851491007511PackageGS150In Commercial Distribution
00851491007517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085149100751410851491007514
2085149100751120851491007511
00851491007517008514910075178514910075170851491007517

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral intravenous catheterization support kitA collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-248-560-4500customerservie@lynnmed.com

Regulatory Flags#

DUNS number
058810771
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851491007333AccuGelAG-50CL-HVAG-50CL-HV2017-02-13
00851491007364AccuGelAG-08AG-082017-02-13
00851491007340AccuGelAG-50AG-502017-02-13
00851491007531AccuSensor915-100915-1002020-08-31
10851491007538AccuSensor915-100915-1002020-08-31
00851491007548AccuSensor910-100910-1002020-06-25
00851491007487Direct IV Solutions - IV Start Kit2533-20G2533-20G2020-04-23
00851491007500Direct IV Solutions - IV Start Kit2534-20G2534-20G2020-04-23
00851491007524Direct IV Solutions - IV Start Kit2534-22G2534-22G2020-04-23
20851491007481Direct IV Solutions - IV Start Kit2533-20G2533-20G2020-04-23
10851491007507Direct IV Solutions - IV Start Kit2534-20G2534-20G2020-04-23
10851491007514Direct IV Solutions - IV Start Kit2533-22G2533-22G2020-04-23
10851491007521Direct IV Solutions - IV Start Kit2534-22G2534-22G2020-04-23
00851491007470Lynn Medical - Ambulatory Kit3111353111352018-10-24
00851491007425Lynn Medical - Ambulatory Kit3112103112102018-10-10
00851491007432Lynn Medical - Ambulatory Kit3112123112122018-10-10
00851491007449Lynn Medical - Ambulatory Kit3112113112112018-10-10
00851491007456Lynn Medical - Ambulatory Kit3112133112132018-10-10
00851491007463Lynn Medical - Ambulatory Kit3112143112142018-10-10
10851491007422Lynn Medical - Ambulatory Kit3112103112102018-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956430235CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-01
10198956431591CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-01
10198956480223CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-01
M689801101006080-110-10 Saline Lock Kit Case of 10Safeguard US Operating, LLCLRS2026-05-29
M68980110150SALINE LOCK KITSafeguard US Operating, LLCLRS2026-05-29
10653160393634MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
10653160393665MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
10653160393689MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
10653160393719MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
09555240405210IV Start KitITL ASIA PACIFIC SDN. BHD.LRS2023-06-28
10193489112672MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-10-25
10193489111880MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-10-01
10193489111811MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-09-24
10193489111781MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-09-17
10193489111668MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-09-03
10193489111675MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-09-03
10193489111606MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-30
10193489111217OTHERMEDLINE INDUSTRIES, INC.LRS2021-08-27
10193489111545MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-20
10193489111552MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-20
10193489111385MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-13
10193489111422MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-13
10193489111446MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-13
10193489110876MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-13
10193489111057MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-13
10193489110883MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-05
10193489110890MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-05
10193489110906MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-05
10193489110913MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-05
10193489110999MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-05