FDA.reportPublic FDA data

Direct IV Solutions - IV Start Kit

Primary DI
00851491007524
Brand
Direct IV Solutions - IV Start Kit
Company
Lynn Medical Instrument Co.
Model
2534-22G
Catalog number
2534-22G
Device description
IV Starter Kit - BD 22G Insyte Catheter, IV Derm Transparent Silicone, Tourniquet, Gauze, Alcohol Prep Pad, & Under Pad
Published
2020-04-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
10851491007521PackageGS1100Not in Commercial Distribution
20851491007528PackageGS150Not in Commercial Distribution
00851491007524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085149100752110851491007521
2085149100752820851491007528
00851491007524008514910075248514910075240851491007524

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral intravenous cannulaA short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851491007555AccuSensorST-50ST-502026-07-28
00851491007562AccuSensorST-50ST-502026-07-24
00851491007142Lynn Medical - Ambulatory Kit3111163111162018-10-08
00851491007487Direct IV Solutions - IV Start Kit2533-20G2533-20G2020-04-23
00851491007500Direct IV Solutions - IV Start Kit2534-20G2534-20G2020-04-23
00851491007517Direct IV Solutions - IV Start Kit2533-22G2533-22G2020-04-23
00851491007012AccuSensor930-100930-1002016-12-09
00851491007029AccuSensor950-100950-1002016-12-09
00851491007036AccuSensor990-100990-1002016-12-09
00851491007043AccuSensor550-048550-0482016-12-09
00851491007128AccuSensor310-050TS310-050TS2016-12-09
00851491007135AccuSensorLM33-1-30LM33-1-302016-12-09
00851491007159AccuSensor630-005630-0052016-12-09
00851491007166AccuSensor630-030630-0302016-12-09
00851491007173AccuSensor690-005690-0052016-12-09
00851491007548AccuSensor910-100910-1002020-06-25
00851491007074AccuSensor510-005510-0052016-12-09
00851491007111AccuSensorST-50ST-502016-12-09
00851491007333AccuGelAG-50CL-HVAG-50CL-HV2017-02-13
00851491007364AccuGelAG-08AG-082017-02-13

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