FDA.reportPublic FDA data

InfiltraLong 420T

Primary DI
14048223019006
Brand
InfiltraLong 420T
Company
Pajunk GmbH Medizintechnologie
Model
001159-00Z
Catalog number
001159-00Z
Device description
InfiltraLong
Published
2016-09-01
Public version status
Update
Distribution status
Not 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
K080675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080675000PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KITPAJUNK GmbH Medizintechnologie2008-06-20BSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14048223019006PrimaryGS10
04048223019009Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404822301900614048223019006
04048223019009040482230190094048223019009

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia conduction catheterization kitA collection of sterile devices and materials intended for the repeated or continuous injection of local anaesthetics for preoperative, intraoperative, or postoperative regional anaesthesia and/or pain management. The kit consists of an anaesthesia catheter with devices dedicated to catheter introduction/function (e.g., tunneller, needle, sheath) and includes non-dedicated supportive devices (e.g., dressings, adhesive strips). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)972-5865info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
10
Lot or batch
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
10801902207811ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207620ARROWTELEFLEX INCORPORATEDBSO2022-07-07
10801902207507ARROWTELEFLEX INCORPORATEDBSO2022-05-13
10801902207835ARROWTELEFLEX INCORPORATEDBSO2022-05-11
10801902207569ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207682ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207743ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207842ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207446ARROWTELEFLEX INCORPORATEDBSO2022-04-11
10801902207668ARROWTELEFLEX INCORPORATEDBSO2022-04-11
10801902207736ARROWTELEFLEX INCORPORATEDBSO2022-04-11