FDA.reportPublic FDA data

Pressure Monitoring Lines

Primary DI
20886333201284
Brand
Pressure Monitoring Lines
Company
ARGON MEDICAL DEVICES, INC.
Model
040304005A
Catalog number
040304005A
Device description
Pressure Monitoring Lines Red 48" Injection Line w/ Male & Female Luer Lock Connectors
Published
2016-09-12
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K781558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K781558000PRESSURE MONITORING INJECTION LINESCobe Laboratories, Inc.1978-10-10DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333201284PackageGS125In Commercial Distribution
00886333201280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633320128420886333201284
00886333201280008863332012808863332012800886333201280

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic procedure tubingA flexible, cylindrical device that typically connects a contrast imaging syringe to a patient cannula for the conduction of contrast media and flushing fluids to a patient during diagnostic radiographic procedures [e.g., angiography or computed tomography (CT)]. The device is made of synthetic polymers, will accommodate low and high pressures, and is provided in various lengths with quick connecting fittings (e.g., Luer-lock).

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
false
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886333209859L-Cath PICC3844663844662026-10-14
00886333006151Skater Nephrostomy Drainage Catheter7556060257556060252026-10-07
00886333006168Skater Nephrostomy Drainage Catheter7556140357556140352026-10-07
00886333006175Skater Nephrostomy Drainage Catheter7556120357556120352026-10-07
00886333006182Skater Nephrostomy Drainage Catheter7556080357556080352026-10-07
00886333006199Skater Nephrostomy Catheter7556100357556100352026-10-07
00886333006205Skater All-Purpose Drainage Catheter7560060207560060202026-10-07
00886333006212Skater All-Purpose Drainage Catheter7560070207560070202026-10-07
00886333006229Skater All-Purpose Drainage Catheter7560120257560120252026-10-07
00886333006236Skater All-Purpose Drainage Catheter7560100257560100252026-10-07
00886333006243Skater All-Purpose Drainage Catheter7560080257560080252026-10-07
00886333006250Skater All-Purpose Drainage Catheter7565140257565140252026-10-07
00886333006267Skater All-Purpose Drainage Catheter7565160257565160252026-10-07
00886333006274Skater All-Purpose Drainage Catheter7565120257565120252026-10-07
00886333006281Skater All-Purpose Drainage Catheter7565100307565100302026-10-07
00886333006298Skater All-Purpose Drainage Catheter7565100257565100252026-10-07
00886333006304Skater All-Purpose Drainage Catheter7565080307565080302026-10-07
00886333006311Skater All-Purpose Drainage Catheter7565080257565080252026-10-07
00886333006328Skater All-Purpose Drainage Catheter7565070257565070252026-10-07
00886333006335Skater All-Purpose Drainage Catheter7565060207565060202026-10-07

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