FDA.reportPublic FDA data

IV Start Kit

Primary DI
00616784469225
Brand
IV Start Kit
Company
Dynarex Corporation
Model
4692
Device description
"IV Start Kit, Sterile,1 Tourniquet (3/4"" x 18""),2 Gauze Sponge (2"" x 2"", 8-Ply),1 ID Label,1 Transparent Dressing,1 Tape (3/4"" x 18""),1 PVP Pad,1 Alcohol Pad "
Published
2022-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRSI.V. Start Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRSI.V. Start KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784469232PackageGS150In Commercial Distribution
00616784469225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784469232006167844692326167844692320616784469232
00616784469225006167844692256167844692250616784469225

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117343764Dynacare Necessities Complete Kit13742026-05-28
00616784812137Drape Sheets, Tissue 2-ply, White, 40" x 48"81212021-09-01
00616784812236Drape Sheets81222021-09-01
00616784812335Drape Sheets81232021-09-01
00616784813134Drape Sheets, Tissue 2-ply, White, 40" x 60"81312021-09-01
00616784813233Drape Sheets81322021-09-01
00616784813332Drape Sheets81332021-09-01
00616784814131Drape Sheets, Tissue 2-ply, White81412021-09-01
00616784815039Drape Sheets, Tissue 2-ply, Blue, 40" x 90"81502021-09-01
00616784815138Drape Sheets, Tissue 2-Ply, white, 40" x 90"81512021-09-01
00616784816135Pillow Cases, Tissue / Poly 2-ply, 21" x 30", White81612021-09-01
00616784890128SecureSafe Safety Insulin Syringe89012017-10-16
00616784890425SecureSafe Safety Insulin Syringe89042017-10-16
00616784892825SecureSafe Syringes With Safety Needle, Non-Toxic, 3 ML, Luer Lock89282017-10-16
00616784711720Disposable Ear Specula Tips For Diagnostic Otoscopes, Adult, 4.25 mm71172021-05-21
00616784418025Bandage Shears 7.5" (19.1 cm) Black41802020-11-08
00616784418124Bandage Shears 7.5" (19.1 cm) Blue41812020-11-08
00616784418223Bandage Shears 7.5" (19.1 cm) Magenta41822020-11-08
00616784418322Bandage Shears 7.5" (19.1 cm) Orange41832020-11-08
00616784418421Bandage Shears 7.5" (19.1 cm) Purple41842020-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10193489110838MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-06-28
10193489110807MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-06-21
10193489110678MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-06-20
10193489110708MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-06-14
10193489110722MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-06-14