FDA.reportPublic FDA data

ARROW

Primary DI
10801902210224
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN925039
Catalog number
MP-17019-TKL
Device description
FlexTip Plus(R) Epidural Catheterization Kit
Published
2022-05-26
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
20801902210221PackageGS15In Commercial Distribution
10801902210224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190221022120801902210221
1080190221022410801902210224

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

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
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841495149457QUIKCLOT1831832026-07-17
10841495149464QUIKCLOT1831832026-07-17
10841495149471QUIKCLOT1881882026-07-17
10841495149488QUIKCLOT1881882026-07-17
10841495149495QUIKCLOT3743742026-07-17
10841495149501QUIKCLOT3743742026-07-17
10841495149518QUIKCLOT4584582026-07-17
10841495149549QUIKCLOT4594592026-07-17
10841495149563QUIKCLOT4604602026-07-17
10841495149587QUIKCLOT4614612026-07-17
10841495149600QUIKCLOT467Z467Z2026-07-17
10841495149624QUIKCLOT4874872026-07-17
14026704930644QUIKCLOT1831832026-07-17
14026704930651QUIKCLOT1831832026-07-17
14026704930668QUIKCLOT1881882026-07-17
14026704930675QUIKCLOT1881882026-07-17
14026704930682QUIKCLOT3743742026-07-17
14026704930699QUIKCLOT3743742026-07-17
14026704930705QUIKCLOT4584582026-07-17
14026704930729QUIKCLOT4594592026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10801902197631ARROWTELEFLEX 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
10801902207620ARROWTELEFLEX INCORPORATEDBSO2022-07-07
10801902207507ARROWTELEFLEX INCORPORATEDBSO2022-05-13