FDA.reportPublic FDA data

Luther Needlesafe Products

Primary DI
00850017259003
Brand
Luther Needlesafe Products
Company
LUTHER NEEDLESAFE PRODUCTS, LLC
Model
18175001
Catalog number
18175001
Device description
Mini-Midline Extended Dwell Peripheral Catheter - 18Ga, 1.75”
Published
2023-05-01
Public version status
Update
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
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130518000MINI-MIDLINE EXTENDED DWELL SAFETY CATHETERLuther Needlesafe Products, Inc.2013-04-30FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850017259000PackageGS150In Commercial Distribution
00850017259003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001725900010850017259000
00850017259003008500172590038500172590030850017259003

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.

Regulatory Flags#

DUNS number
117440613
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017259010Luther Needlesafe Products20150001201500012023-05-01
00850017259027Luther Needlesafe Products20175001201750012023-05-01
00850017259034Luther Needlesafe Products22150001221500012023-05-01
00850017259041Luther Needlesafe Products22175001221750012023-05-01
00850017259058Luther Needlesafe Products24125001241250012023-05-01
10850017259000Luther Needlesafe Products18175001181750012023-05-01
10850017259017Luther Needlesafe Products20150001201500012023-05-01
10850017259024Luther Needlesafe Products20175001201750012023-05-01
10850017259031Luther Needlesafe Products22150001221500012023-05-01
10850017259048Luther Needlesafe Products22175001221750012023-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08032248007123SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007130SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007147SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007154SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007161SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007178SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007185SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007192SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007208SOL CARE T DELTA MED SPAFOZ2021-03-30
08032248007215SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007222SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007239SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007246SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007253SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007260SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007277SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248007284SOL CARE 1 DELTA MED SPAFOZ2021-03-30
08032248007291SOL CARE 1DELTA MED SPAFOZ2021-03-30
08032248005372Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005389Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005396Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005402Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005419Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005426Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005433Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005440Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005457Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005464Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005471Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26
08032248005495Deltaven Fast FlashDELTA MED SPAFOZ2020-10-26