FDA.reportPublic FDA data

NiniFilter NRFit

Primary DI
04048223031315
Brand
NiniFilter NRFit
Company
Pajunk GmbH Medizintechnologie
Model
001163-38K
Catalog number
001163-38K
Published
2020-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSNFILTER, CONDUCTION, ANESTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSNFilter, Conduction, AnestheticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190663000Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6PAJUNK GmbH Medizintechnologie2019-06-17BSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048223049877PrimaryGS10
14048223031312PrimaryGS10
04048223031315Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223049877040482230498774048223049877
1404822303131214048223031312
04048223031315040482230313154048223031315

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia conduction filterA sterile microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during administration to a patient (e.g., through an anaesthesia conduction catheter). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)972-5865info@pajunk-usa.com
+1 770-493-6832info@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
false
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
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
04048223120316FilterPajunk GmbH MedizintechnologieBSN2025-04-04
04048223120323FilterPajunk GmbH MedizintechnologieBSN2025-04-04
04048223069585MiniFilter 0,2µmPajunk GmbH MedizintechnologieBSN2025-01-30
04048223048993MiniFilter 0,2µmPajunk GmbH MedizintechnologieBSN2025-01-30
00840178703477ITDTouchpoint Medical, Inc.BSN2024-09-16
05060498301411Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301442Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301565Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301688Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306881Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306904Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306980Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301435Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301459Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301572Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301695Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302289Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302265Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302104Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306911Dash 6INTERVENE GROUP LIMITEDBSN2023-06-02
05060498302227Dash 6INTERVENE GROUP LIMITEDBSN2023-06-02
04048223049877FILTERPajunk GmbH MedizintechnologieBSN2021-04-02
04048223050064FILTERPajunk GmbH MedizintechnologieBSN2021-04-02
14048223031312NiniFilter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
14048223041793Filter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
04048223041796Filter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
15019315107283PortexICU MEDICAL, INC.BSN2020-06-22
35019315107287PortexSmiths Medical Czech Republic a.s.BSN2020-06-22
15019517054651PortexICU MEDICAL, INC.BSN2020-03-09
15019517071368PortexICU MEDICAL, INC.BSN2020-03-09