FDA.reportPublic FDA data

ClampingAdapter -yellow-

Primary DI
04048223131176
Brand
ClampingAdapter -yellow-
Company
Pajunk GmbH Medizintechnologie
Model
001151-37V
Catalog number
001151-37V
Device description
ClampingAdapter -yellow- sterile
Published
2025-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K172777000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172777000Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7PAJUNK GmbH Medizintechnologie2018-05-03BSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048223132555PackageGS110In Commercial Distribution
04048223048894PreviousGS10
04048223131176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223132555040482231325554048223132555
04048223048894040482230488944048223048894
04048223131176040482231311764048223131176

GMDN Terms#

Term, Definition table
TermDefinition
Luer/epidural catheter linear connectorA small, non-powered, noninvasive tubular device with a Luer connection (either lock or slip) at one end and an epidural catheter adapting mechanism at the other end, intended to connect an external device with a Luer connection (e.g., syringe) with an epidural catheter with no pre-existing connector. It is designed to connect over the epidural catheter and seal the connection with either an integrated clamping mechanism or by means of an adhesive port. It does not incorporate a valve, tubing nor puncturing component. This is a single-use device.

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
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10801902200614ARROWTELEFLEX INCORPORATEDBSO2022-11-09
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10801902207507ARROWTELEFLEX INCORPORATEDBSO2022-05-13
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10801902207569ARROWTELEFLEX INCORPORATEDBSO2022-04-29
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10801902207842ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207446ARROWTELEFLEX INCORPORATEDBSO2022-04-11
10801902207668ARROWTELEFLEX INCORPORATEDBSO2022-04-11
10801902207736ARROWTELEFLEX INCORPORATEDBSO2022-04-11