FDA.reportPublic FDA data

ARROW

Primary DI
20801902197942
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN920801
Catalog number
AK-09001
Device description
Peritoneal Lavage
Published
2022-11-09
Public version status
New
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
GBWCATHETER, PERITONEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBWCatheter, PeritonealGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K811627000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811627000ARROW PERITONEAL LAVAGE CATHERIZATION KArrow Intl., Inc.1981-08-10GBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902197942PackageGS110In Commercial Distribution
10801902197945PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190219794220801902197942
1080190219794510801902197945

GMDN Terms#

Term, Definition table
TermDefinition
Pleural/peritoneal drainage catheterization kitA collection of sterile devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions, ascites, and/or air. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller). It also includes additional non-dedicated catheterization support devices (e.g., disposable scissors, gloves, 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002348191
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380208942JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208959JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208966JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208973JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208980JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380208997JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209000JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209017JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209024JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209031JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209048JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209055JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209062JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209079JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209086JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209093JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209109JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209116JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209123JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209130JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209147JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209154JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209161JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209178JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209185JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209192JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209208JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
10885380209215JACKSON-PRATTCardinal Health 200, LLCGBW2026-05-11
14026704912794TAUTTELEFLEX INCORPORATEDGBW2024-06-19
14026704912800TAUTTELEFLEX INCORPORATEDGBW2024-06-19