FDA.reportPublic FDA data

InfiltraLong set consisting of:

Primary DI
14048223016692
Brand
InfiltraLong set consisting of:
Company
Pajunk GmbH Medizintechnologie
Model
001158-40C
Catalog number
001158-40C
Device description
InfiltraLong set consisting of: InfiltraLong catheter 19G x 900mm with integrated metal spiral with 88 drill
Published
2016-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14048223016692PrimaryGS10
04048223016695Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404822301669214048223016692
04048223016695040482230166954048223016695

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
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
true
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
04048223126103NerveStim Pure1151-94-901151-94-902026-02-06
04048223128817SPROTTE®511151-29A511151-29A2025-09-16
04048223129111SPROTTE® NRFit051163-29A051163-29A2025-09-16
04048223129517SPROTTE® NRFit041163-29A041163-29A2025-09-16
04048223129647SPROTTE®071151-30C071151-30C2025-09-16
04048223129678SPROTTE® NRFit021163-30C021163-30C2025-09-16
04048223129692SPROTTE® NRFit031163-27A031163-27A2025-09-16
04048223129838SPROTTE® NRFit061163-29A061163-29A2025-09-16
04048223129999Standard Sprotte Needle321151-29A321151-29A2025-09-16
04048223131398Standard Sprotte Needle341151-31B341151-31B2025-09-16
04048223131428SPROTTE®131151-30C131151-30C2025-09-16
04048223131442SPROTTE®131151-30A131151-30A2025-09-16
04048223131466SPROTTE®141151-30C141151-30C2025-09-16
04048223132050SonoPlex® II Facet S001287-72001287-722025-09-16
04048223132135SonoPlex® II Facet S001287-76001287-762025-09-16
04048223132241SonoPlex® II Facet NRFit001265-74001265-742025-09-16
04048223132319SonoPlex® II Facet NRFit001265-77001265-772025-09-16
04048223132395SonoPlex® II Facet001285-76001285-762025-09-16
04048223132463SonoBlock II Facet001280-74001280-742025-09-16
04048223132562SonoPlex® II Facet S NRFit001267-76001267-762025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223132210InfiltraLong 700Pajunk GmbH MedizintechnologieBSO2025-07-30
20801902223658ARROWTELEFLEX INCORPORATEDBSO2025-07-21
04048223128978E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223128985E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223128992E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129029E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129043E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129067E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129074E-Cath® STIM Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129128E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129166E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129258E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129265E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129272E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129289E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129333E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129388E-Cath® Plus Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223129579InfiltraLongPajunk GmbH MedizintechnologieBSO2025-06-17
04048223129609InfiltraLong 500TPajunk GmbH MedizintechnologieBSO2025-06-17
04048223129623InfiltraLongPajunk GmbH MedizintechnologieBSO2025-06-17
04048223129661InfiltraLong 600TPajunk GmbH MedizintechnologieBSO2025-06-17
04048223129760InfiltraLongPajunk GmbH MedizintechnologieBSO2025-06-17
04048223129876E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223132180InfiltraLong 600Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223132203InfiltraLong 500Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223132227InfiltraLong 600TPajunk GmbH MedizintechnologieBSO2025-06-17
04048223132265InfiltraLong 900Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223132401InfiltraLong 420Pajunk GmbH MedizintechnologieBSO2025-06-17
04048223132432InfiltraLong SonoPajunk GmbH MedizintechnologieBSO2025-06-17
04048223133187E-Cath® Tsui®Pajunk GmbH MedizintechnologieBSO2025-06-17