FDA.reportPublic FDA data

Clamping Adapter NRFit -white-

Primary DI
14048223033088
Brand
Clamping Adapter NRFit -white-
Company
Pajunk GmbH Medizintechnologie
Model
001163-38C
Catalog number
001163-38C
Device description
Clamping Adapter NRFit -white- sterile
Published
2018-05-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
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
14048223033088PrimaryGS10
04048223033081Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404822303308814048223033088
04048223033081040482230330814048223033081

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose catheter connector, sterileA small sterile device intended to create a mechanical union between a catheter and an external device (non-dedicated) typically via a Luer connection; it has an intended use profile that is not dedicated to a specific type of catheter (i.e., can be applied to catheters specific to different anatomical sites and body fluids). It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. 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
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048223056165VASCULAR SONO1187-4F0351187-4F0352021-04-02
04048223056172VASCULAR SONO1187-4F0701187-4F0702021-04-02
04048223056189VASCULAR SONO1187-4K0401187-4K0402021-04-02
04048223056196VASCULAR SONO1187-4K0701187-4K0702021-04-02
04048223056202VASCULAR SONO1187-4K1001187-4K1002021-04-02
04048223115947VASCULAR SONO1187-4F0351187-4F0352021-07-07
04048223115954VASCULAR SONO1187-4F0701187-4F0702021-07-07
04048223115961VASCULAR SONO1187-4K0401187-4K0402021-07-07
04048223115978VASCULAR SONO1187-4K0701187-4K0702021-07-07
04048223115985VASCULAR SONO1187-4K1001187-4K1002021-07-07
04048223126561VascularSono1187-4K0701187-4K0702025-06-17
04048223126653VascularSono1187-4K1001187-4K1002025-11-04
04048223126721VascularSono1187-4F0701187-4F0702025-11-04
14048223021153VascularSono1187-4K0701187-4K0702016-08-31
14048223021160VascularSono1187-4K1001187-4K1002016-08-31
14048223021344VascularSono1187-4F0351187-4F0352016-08-31
14048223021504VascularSono1187-4K0401187-4K0402016-08-31
14048223021603VascularSono1187-4F0701187-4F0702016-08-31
04048223122655Tuohy II1170-6I0911170-6I0912026-10-22
04048223122679Tuohy II1170-6K0811170-6K0812026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04048223085073E-Cath® Plus NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223085554E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223086087E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223086261E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
10801902155945ARROWTELEFLEX INCORPORATEDBSO2025-03-10
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10801902207521ARROWTELEFLEX INCORPORATEDBSO2022-09-14
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10801902207699ARROWTELEFLEX INCORPORATEDBSO2022-09-14
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