FDA.reportPublic FDA data

First PICC™ D/L Peripherally Inserted Central Catheter

Primary DI
00886333209705
Brand
First PICC™ D/L Peripherally Inserted Central Catheter
Company
ARGON MEDICAL DEVICES, INC.
Model
384159
Catalog number
384159
Device description
First PICC™ D/L Peripherally Inserted Central Catheter 16ga (5F) 1.75mm x 65cm
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K972263000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972263000FIRST PICC CATHETER WITH DUAL LUMENSBecton Dickinson Infusion Therapy Systems, Inc.1997-09-15FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333209709PackageGS15Not in Commercial Distribution
00886333209705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633320970920886333209709
00886333209705008863332097058863332097050886333209705

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and Away from Sunlight

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
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
00886333226931Micro-Access Introducer4978374978372026-10-07
00886333226948Micro-Access Introducer4978394978392026-10-07
00886333004171V•Stick™ Vascular Access Set390204400E390204400E2016-09-16
00886333004188V•Stick™ Vascular Access Set391504000E391504000E2016-09-16
00886333004195V•Stick™ Vascular Access Set391504300E391504300E2016-09-16
00886333004201V•Stick™ Vascular Access Set391504400E391504400E2016-09-16
00886333004218V•Stick™ Vascular Access Set391504500E391504500E2016-09-16
00886333004225V•Stick™ Vascular Access Set391505000E391505000E2016-09-16
00886333004232V•Stick™ Vascular Access Set391505300E391505300E2016-09-16
00886333004249V•Stick™ Vascular Access Set391505400E391505400E2016-09-16
00886333004256V•Stick™ Vascular Access Set391505500E391505500E2016-09-16
00886333004263V•Stick™ Vascular Access Set391605300E391605300E2016-09-16
00886333004270V•Stick™ Vascular Access Set391604000E391604000E2016-09-16
00886333004287V•Stick™ Vascular Access Set391604300E391604300E2016-09-16
00886333004294V•Stick™ Vascular Access Set391604400E391604400E2016-09-16
00886333004300V•Stick™ Vascular Access Set391604500E391604500E2016-09-16
00886333004317V•Stick™ Vascular Access Set391605000E391605000E2016-09-16
00886333004324V•Stick™ Vascular Access Set391605400E391605400E2016-09-16
00886333004331V•Stick™ Vascular Access Set391605500E391605500E2016-09-16
00886333007042V•Stick™ Vascular Access Set391705400E391705400E2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253040241ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040258ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040265ArgyleCardinal Health 200, LLCFOZ2025-01-08
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