FDA.reportPublic FDA data

Manifold

Primary DI
00886333207091
Brand
Manifold
Company
ARGON MEDICAL DEVICES, INC.
Model
193135
Catalog number
193135
Device description
4 Port Manifold - Right/Off/Open Body - 500 PSI
Published
2016-09-09
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
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K915301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915301000ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCKAdvance Medical Designs, Inc.1992-12-11DTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333207095PackageGS125Not in Commercial Distribution
00886333207091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633320709520886333207095
00886333207091008863332070918863332070910886333207091

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Device Sizes#

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

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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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