FDA.reportPublic FDA data

ARROW

Primary DI
10801902121728
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN036986
Catalog number
AK-09000
Device description
Peritoneal Lavage Kit
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
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
40801902121729PackageGS110Not in Commercial Distribution
10801902121728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4080190212172940801902121729
1080190212172810801902121728

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
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704936882WECK5442345442342026-10-20
14026704936899WECK5442445442442026-10-20
14026704936905WECK5442545442542026-10-20
14026704936912WECK5442325442322026-10-20
14026704936929WECK5442425442422026-10-20
14026704936936WECK5442525442522026-10-20
14026704936943WECK5442325442322026-10-20
14026704936950WECK5442345442342026-10-20
14026704936967WECK5442425442422026-10-20
14026704936974WECK5442445442442026-10-20
14026704936981WECK5442525442522026-10-20
14026704936998WECK5442545442542026-10-20
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29

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