FDA.reportPublic FDA data

EpiLong Cath

Primary DI
04048223090480
Brand
EpiLong Cath
Company
Pajunk GmbH Medizintechnologie
Model
001151-37C
Catalog number
001151-37C
Device description
EpiLong Cath 20G x 90cm with closed tip, radiopaque line,
Published
2025-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAZAnesthesia conduction kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060311000EPILONG KIT FOR ANESTHESIOLOGYPAJUNK GmbH Medizintechnologie2006-06-13CAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048223100332PackageGS110In Commercial Distribution
04048223090480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223100332040482231003324048223100332
04048223090480040482230904804048223090480

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia stand-alone catheterA flexible tube, supplied in isolation of other devices, intended to be percutaneously introduced into the epidural space for the delivery of an anaesthetic/analgesic agent; it is not coated with an antimicrobial agent. It is intended to be introduced using an epidural needle, however neither the needle nor other procedural assistive devices are included (i.e., the catheter is sold alone and this is not an epidural set). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length900Millimeter
Needle Gauge20Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1 770-493-6832info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
1
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
04048223084366EpiLong Soft NRFit1432167-511432167-512026-05-21
04048223122235Stim2Go9151-10-009151-10-002026-05-21
04048223126103NerveStim Pure1151-94-901151-94-902026-02-06
14048223031312NiniFilter NRFit001163-38K001163-38K2020-07-22
14048223041793Filter NRFit001163-39F001163-39F2020-07-22
04048223048917FILTER001151-37X001151-37X2021-04-02
04048223049877FILTER001163-38K001163-38K2021-04-02
04048223050064FILTER001163-39F001163-39F2021-04-02
04048223069462Flat filter 0,2µm round001151-37Q001151-37Q2025-01-30
04048223069585MiniFilter 0,2µm001151-38K001151-38K2025-01-30
04048223070598Filter cannula NRFit001163-38Y001163-38Y2025-01-30
04048223120316Filter001151-62001151-622025-04-04
14048223016593Filter 0,2µm001151-37X001151-37X2016-09-29
14048223018993Quincke1149-3E1201149-3E1202020-11-03
14048223032777Tuohy cannula1150-7G1031150-7G1032020-06-09
14048223034443Tuohy1150-4G1031150-4G1032020-11-16
14048223036720UniMSK1192-4E1201192-4E1202020-07-02
14048223036737UniMSK1192-4E1501192-4E1502020-07-02
14048223038946Tuohy1150-4E1201150-4E1202020-05-06
14048223038953Tuohy1150-4G1201150-4G1202020-07-02

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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
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10381780527404Integra®INTEGRA PAIN MANAGEMENTCAZ2019-05-13
10381780527015Integra®INTEGRA PAIN MANAGEMENTCAZ2019-03-05
10381780511465Integra®INTEGRA PAIN MANAGEMENTCAZ2019-02-27
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10381780491316Integra®INTEGRA PAIN MANAGEMENTCAZ2018-08-16
10381780464792Integra®INTEGRA PAIN MANAGEMENTCAZ2018-07-16
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
10381780466611Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780486756Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780486763Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780429487Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429494Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429524Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429562Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429586Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429593Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429609Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20
10381780429616Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-20