FDA.reportPublic FDA data

ARROW

Primary DI
40801902114448
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN045732
Catalog number
ASK-17019-WF1
Device description
EPIDURAL CATHETERIZATION KIT
Published
2018-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSOCATHETER, CONDUCTION, ANESTHETIC
CAZAnesthesia conduction kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSOCatheter, Conduction, AnestheticAnesthesiology2
CAZAnesthesia Conduction KitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103658000
K140110000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103658000FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTERTeleflex, Inc.2012-05-16CAZ
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
40801902114448PackageGS15In Commercial Distribution
30801902114441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4080190211444840801902114448
3080190211444130801902114441

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia conduction catheterA flexible tube intended to be percutaneously introduced for the repeated or continuous injection of local anaesthetics for preoperative, intraoperative, or postoperative regional anaesthesia and/or pain management; it may be placed in the epidural space, into or around surgical wound sites, and near peripheral nerves. It may include devices dedicated to catheter introduction/function (e.g., needle, sheath); it is not coated with an antimicrobial agent. This device is typically used during surgical or diagnostic procedures or for the temporary relief of chronic pain in the limbs, pelvis, abdomen, or lumbar spine. This is a single-use device intended to be used in a sterile condition.

Storage And Handling#

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

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
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
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
10193489490312Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAZ2022-08-04
10193489031768MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031775MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031782MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031799MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
08809544172141EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172158EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172165EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172172EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172189EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172196EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172202EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172219EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172226EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172233EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172240EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172257EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172264EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172271EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172288EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
08809544172295EPINAUTIMEDICOM CO., LTD.BSO2018-09-21
10381780429531Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431640Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431657Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431749Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431763Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431770Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780429487Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429494Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429524Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20