FDA.reportPublic FDA data

ARROW

Primary DI
40801902012058
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN046485
Catalog number
MM-05501
Device description
Epidural Catheterization Kit with FlexTip Plus(R) Catheter
Published
2018-11-07
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
40801902012058PackageGS110In Commercial Distribution
50801902012055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4080190201205840801902012058
5080190201205550801902012055

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0Centimeter

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
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
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
00801902003362ARROWIPN035388CC-017002026-08-03
00850921007417ARROWIPN919634DLX-200-USC2026-08-03
04026704916955RUSCHIPN9007315640002026-08-03
04026704934812TELEFLEXIPN931133ST192026-08-03
05060112310058LMA AIRWAY MANAGEMENTIPN9016471000152026-08-03
05060112310065LMA AIRWAY MANAGEMENTIPN9016491000202026-08-03
05060112310607LMA AIRWAY MANAGEMENTIPN9018611500152026-08-03
10801902170191ARROWIPN917307CS-017012026-08-03
10801902206241ARROWIPN922981PW-18080-HS2026-08-03
10801902215168ARROWIPN9280309001T-VC-0052026-08-03
10801902219210ARROWIPN929382CV-15123-F2026-08-03
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
14026704730466PILLINGIPN924356P358PRA2026-08-03
14026704934758LMA AIRWAY MANAGEMENTIPN9292541360652026-08-03
14026704934765LMA AIRWAY MANAGEMENTIPN9292561360752026-08-03
14026704934772LMA AIRWAY MANAGEMENTIPN9292571360802026-08-03
14026704934802LMA AIRWAY MANAGEMENTIPN9292551360702026-08-03
00801902004857ARROWIPN033843AK-040202016-09-16
05060112310041LMA AIRWAY MANAGEMENTIPN9016451000102026-07-31
05060112310621LMA AIRWAY MANAGEMENTIPN9018661500252026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902197716ARROWTELEFLEX INCORPORATEDBSO2026-07-30
14026704737403ARROWTELEFLEX INCORPORATEDBSO2026-07-30
10801902209471ARROWTELEFLEX INCORPORATEDCAZ2026-07-29
10801902211405ARROWTELEFLEX INCORPORATEDBSO2026-07-29
10801902217193ARROWTELEFLEX INCORPORATEDCAZ2026-07-29
15019517332063PortexICU MEDICAL, INC.CAZ2026-07-27
10801902202243ARROWTELEFLEX INCORPORATEDCAZ2026-07-13
10801902221725ARROWTELEFLEX INCORPORATEDBSO2026-06-24
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04048223070130InfiltraLong 420Pajunk GmbH MedizintechnologieBSO2026-06-10
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04048223074787EpiSpin Safety NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223074800EpiSpin Safety NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223084182EpiLong NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
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
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04048223086261E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223088005SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088050PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088661SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088692SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088708PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088722PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223089873LOR NRFit 10ml, SlipPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223090466EpiLong CathPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223125267SonoLong SoftSecurePajunk GmbH MedizintechnologieCAZ2026-06-10
05060498301534Dash 6GBUK GROUP LIMITEDBSO2024-01-22
05060498306959Dash 6GBUK GROUP LIMITEDBSO2023-06-02