FDA.reportPublic FDA data

MANOMETER

Primary DI
04048223049860
Brand
MANOMETER
Company
Pajunk GmbH Medizintechnologie
Model
001163-38F
Catalog number
001163-38F
Device description
001163-38F
Published
2021-04-02
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
FMJMANOMETER, SPINAL-FLUID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMJManometer, Spinal-FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170305000Spinal Manometer NRFit; Spinal Manometer LUERPAJUNK GmbH Medizintechnologie2017-07-25FMJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14048223029777PreviousGS10
04048223049860PrimaryGS10
04048223029770Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404822302977714048223029777
04048223049860040482230498604048223049860
04048223029770040482230297704048223029770

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid manometer, mechanicalA sterile device designed to directly measure the cerebrospinal fluid (CSF) pressure in a patient. It is a mechanical instrument that connects with a dedicated hollow needle inserted into the subarachnoid (intrathecal) space of the lumbar section of the spinal column; CSF pressure is typically displayed on a dial showing readings in, e.g., cmH2O or mmH2O. Connectors, tubing, and the spinal needle are typically included. The device is intended to be used to determine variations in CSF pressure for the purposes of diagnosing, assessing trauma, or to evaluate some other clinical condition (e.g., tumours). 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

Contacts#

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

Regulatory Flags#

DUNS number
317654283
Device count
10
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223131374Spinal Manometer NRFitPajunk GmbH MedizintechnologieFMJ2025-11-19
04048223131046Manometer Extension Tube - 20cmPajunk GmbH MedizintechnologieFMJ2025-06-17
04048223132425Manometer Extension Tube - 20cmPajunk GmbH MedizintechnologieFMJ2025-06-17
04048223069578Spinal ManometerPajunk GmbH MedizintechnologieFMJ2025-01-30
04048223048986Spinal ManometerPajunk GmbH MedizintechnologieFMJ2025-01-30
00849233008779Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2022-11-10
00849233008762Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2022-11-04
00849233008809Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2022-11-04
10849233008769Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2022-11-04
10849233008806Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2022-11-04
04048223049204MANOMETERPajunk GmbH MedizintechnologieFMJ2021-04-02
00849233004917Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-09-10
10849233004914Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-09-10
14048223022563Manometer Extension Tube - 20cmPajunk GmbH MedizintechnologieFMJ2020-07-15
04048223022566Manometer Extension Tube - 20cmPajunk GmbH MedizintechnologieFMJ2020-07-15
14048223029777Spinal Manometer NRFitPajunk GmbH MedizintechnologieFMJ2020-07-06
04048223029770Spinal Manometer NRFitPajunk GmbH MedizintechnologieFMJ2020-07-06
00849233000247Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-04-09
00849233003064Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-04-09
00849233010369Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-04-09
10849233000244Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-04-09
10849233003061Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-04-09
10849233010366Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2020-04-09
10884521020344CurityCardinal Health, Inc.FMJ2016-09-24
10884521020405CurityCardinal Health, Inc.FMJ2016-09-24
20884521020402CurityCardinal Health, Inc.FMJ2016-09-24
20884521020341CurityCardinal Health, Inc.FMJ2016-09-24
20884521020365CurityCardinal Health, Inc.FMJ2016-09-24
00849233004283Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2016-09-14
00849233000742Busse Hospital DisposablesROBERT BUSSE & CO., INC.FMJ2016-09-13