FDA.reportPublic FDA data

ARROW

Primary DI
10801902197631
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN920769
Catalog number
JC-05400-DCS
Device description
FlexTip Plus(R) Epidural Catheterization Set
Published
2022-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSOCATHETER, CONDUCTION, ANESTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSOCatheter, Conduction, AnestheticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140110000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140110000FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SETTeleflex, Inc.2015-03-27BSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902197638PackageGS120In Commercial Distribution
10801902197631PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190219763820801902197638
1080190219763110801902197631

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia 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
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10841156108502ONCONTROLIPN9190199458-VC-0062021-10-29
10841156108564ONCONTROLIPN9190259463-VC-0062021-10-29
10841156108601ONCONTROLIPN9190299465-VC-0062021-10-29
10841156108632ONCONTROLIPN9190329468-VC-0062022-01-20
10841156108649ONCONTROLIPN9190339471-VC-0062022-01-21
10841156108656ONCONTROLIPN9190349472-VC-0062021-10-29
10841156108663ONCONTROLIPN9190359490-VC-0062022-01-20
10841156108670ONCONTROLIPN9190159408-VC-0062021-10-29
10801902228045ARROWAK-05503AK-055032026-10-09
10801902228052ARROWSJ-05501SJ-055012026-10-09
10801902228069ARROWAB-05060-PKAB-05060-PK2026-10-09
10801902228076ARROWMP-17019-TKLMP-17019-TKL2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902197716ARROWTELEFLEX INCORPORATEDBSO2026-07-30
14026704737403ARROWTELEFLEX INCORPORATEDBSO2026-07-30
10801902211405ARROWTELEFLEX INCORPORATEDBSO2026-07-29
10801902221725ARROWTELEFLEX INCORPORATEDBSO2026-06-24
04048223070130InfiltraLong 420Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223085066E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223085073E-Cath® Plus NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223085554E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223086087E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223086261E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
10801902155945ARROWTELEFLEX INCORPORATEDBSO2025-03-10
05060498301534Dash 6GBUK GROUP LIMITEDBSO2024-01-22
05060498306959Dash 6GBUK GROUP LIMITEDBSO2023-06-02
10801902189148ARROWTELEFLEX INCORPORATEDBSO2022-11-29
10801902197570ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902197587ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902197723ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902197730ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902200614ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902201444ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902201468ARROWTELEFLEX INCORPORATEDBSO2022-11-09
10801902192636ARROWTELEFLEX INCORPORATEDBSO2022-11-08
10801902194579ARROWTELEFLEX INCORPORATEDBSO2022-11-08
10801902194586ARROWTELEFLEX INCORPORATEDBSO2022-11-08
10801902207484ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207521ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207545ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207699ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207705ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207712ARROWTELEFLEX INCORPORATEDBSO2022-09-14