FDA.reportPublic FDA data

ARROW

Primary DI
00801902083517
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN034163
Catalog number
ASK-00376-JHH
Device description
Large Volume Abdominal Paracentesis Kit with Sharps Safety Features
Published
2016-09-16
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOLCATHETER AND TIP, SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30801902083518PackageGS16Not in Commercial Distribution
00801902083517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3080190208351830801902083518
00801902083517008019020835178019020835170801902083517

GMDN Terms#

Term, Definition table
TermDefinition
Pleural/peritoneal drainage catheterization kit, non-medicatedA collection of non-powered devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions (e.g., haemothorax, empyema, ascites), other fluids, and/or air; some types are additionally intended for infusion of fluids/materials into the pleural/peritoneal space. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller), non-dedicated catheterization support devices (e.g., dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902228045ARROWAK-05503AK-055032026-10-09
10801902228052ARROWSJ-05501SJ-055012026-10-09
10801902228069ARROWAB-05060-PKAB-05060-PK2026-10-09
10801902228076ARROWMP-17019-TKLMP-17019-TKL2026-10-09
10801902228083ARROWAK-05560AK-055602026-10-09
10801902228090ARROWAK-05502AK-055022026-10-09
10801902228106ARROWAK-05501AK-055012026-10-09
10841156108526ONCONTROLIPN9190219461-VC-0062022-01-21
10841156108540ONCONTROLIPN9190239462-VC-0062021-10-29
10841156108588ONCONTROLIPN9190279464-VC-0062021-10-29
10841156108625ONCONTROLIPN9190319466-VC-0062021-10-29
14026704610904LMAIPN046748V1750152018-09-15
14026704610928LMAIPN046750V1750252018-09-15
14026704640277RUSCHIPN0499450044511002019-04-23
14026704641779RUSCHIPN0499380044311002019-04-24
14026704641793RUSCHIPN0499410044335002019-04-24
14026704641816RUSCHIPN0499430044490002019-04-24
14026704641823RUSCHIPN0499440044500502019-04-24
05060112311918LMAIPN046959V1250302018-09-15
10801902226119ARROWPR-45563-BASPR-45563-BAS2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436384MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436391MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436407MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436414MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436421MillenniumAvalign Technologies, Inc.JOL2026-10-08
00190776436469MilleniumAvalign Technologies, Inc.JOL2026-10-08
00190776436476MilleniumAvalign Technologies, Inc.JOL2026-10-08
00190776436483MilleniumAvalign Technologies, Inc.JOL2026-10-08
B382SD9115011000Surgical DirectSurgical Direct, Inc.JOL2026-09-30
00850088713787PRINCETONPrinceton Medical Group, Inc.JOL2026-09-22
00190776423803MillenniumAvalign Technologies, Inc.JOL2026-08-26
04250603753148LAZICPeter Lazic GmbHJOL2026-08-25
04250603753155LAZICPeter Lazic GmbHJOL2026-08-25
04250603753162LAZICPeter Lazic GmbHJOL2026-08-25
04250603753179LAZICPeter Lazic GmbHJOL2026-08-25
04250603753186LAZICPeter Lazic GmbHJOL2026-08-25
04250603753193LAZICPeter Lazic GmbHJOL2026-08-25
00190776408695MillenniumAvalign Technologies, Inc.JOL2026-08-03
00190776408725MillenniumAvalign Technologies, Inc.JOL2026-08-03
00190776422813MillenniumAvalign Technologies, Inc.JOL2026-08-03
B382SD911424030Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424050Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD911424060Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114241000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114251000Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143009NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114301120Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD91143012NC0Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311010Surgical DirectSurgical Direct, Inc.JOL2026-07-23
B382SD9114311060Surgical DirectSurgical Direct, Inc.JOL2026-07-23