FDA.report

L-CathTM PICC D/L

Primary DI
20886333209976
Brand
L-CathTM PICC D/L
Company
ARGON MEDICAL DEVICES, INC.
Model
20GA (2.6F) x 60cm
Catalog number
384566
Device description
Peripherally Inserted Central Catheter Basic Kit
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LJSCatheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Product Code Classifications

CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20886333209976PackageGS15In Commercial Distribution
00886333209972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633320997620886333209976
00886333209972008863332099728863332099720886333209972

GMDN Terms

TermDefinition
Peripherally-inserted central venous catheterA sterile, thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
1.800.927.4669customer.service@argonmedical.com

Regulatory Flags

DUNS number
140727624
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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20886333227505ClosureFast GuidewireGW-035-45GW-035-452024-07-29
20886333227512ClosureFast Introducer Sheath IS-7F07IS-7F072024-07-29
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