FDA.reportPublic FDA data

EpiLong Cath

Primary DI
04048223090466
Brand
EpiLong Cath
Company
Pajunk GmbH Medizintechnologie
Model
001151-37A
Catalog number
001151-37A
Device description
EpiLong Cath 19G x 90cm with closed tip, radiopaque line,
Published
2026-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
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
04048223100318PackageGS110In Commercial Distribution
04048223090466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223100318040482231003184048223100318
04048223090466040482230904664048223090466

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
Catheter Gauge0
Catheter Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
317654283
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048223049860MANOMETER001163-38F001163-38F2021-04-02
04048223050163RFTL001165-20C001165-20C2021-04-02
04048223050248RFTL001165-30D001165-30D2021-04-02
04048223051757SONOPLEX001285-71001285-712021-04-02
04048223051801SONOPLEX001285-77001285-772021-04-02
04048223052303RFTL011165-40D011165-40D2021-04-02
04048223102541UNIPLEX® NANOLINE001156-72001156-722021-04-02
04048223102572UNIPLEX® NANOLINE001156-77001156-772021-04-02
04048223103319SONOBLOCK001180-71001180-712021-04-02
04048223103449SONOPLEX001185-71001185-712021-04-02
04048223103463SONOPLEX001185-74001185-742021-04-02
04048223103562SONOPLEX001187-74001187-742021-04-02
04048223107058SONOTAP1185-3E0501185-3E0502021-04-02
04048223115756TUOHY1150-7G1031150-7G1032021-07-07
04048223116043SONO MSK1191-4C0501191-4C0502021-07-07
04048223116074SONO MSK1191-4E0701191-4E0702021-07-07
04048223116081SONO MSK1191-4E0901191-4E0902021-07-07
04048223116098SONO MSK1191-4E1001191-4E1002021-07-07
04048223116265SONOTAP II1285-3E0501285-3E0502021-07-07
04048223116272SONOTAP II1285-3E0801285-3E0802021-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223070116UniPlex® NanoLine®Pajunk GmbH MedizintechnologieCAZ2026-06-10
04048223073056EpiLong CathPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223074787EpiSpin Safety NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223074800EpiSpin Safety NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223084182EpiLong NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
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
04048223125267SonoLong SoftSecurePajunk GmbH MedizintechnologieCAZ2026-06-10
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
04048223116869PLEXOLONGPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223116883PLEXOLONGPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117088STIMULONG SONOPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117187PLEXOLONG NANOPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117309SONOLONG ECHOPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117422SONOLONG ECHOPajunk GmbH MedizintechnologieCAZ2021-07-07
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