FDA.reportPublic FDA data

Spinal Manometer

Primary DI
04048223048986
Brand
Spinal Manometer
Company
Pajunk GmbH Medizintechnologie
Model
001151-38G
Catalog number
001151-38G
Device description
Spinal Manometer with three-way cock
Published
2025-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
04048223048986PackageGS110In Commercial Distribution
04048223069578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223048986040482230489864048223048986
04048223069578040482230695784048223069578

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 Humidity20 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

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
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
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
04048223049860MANOMETERPajunk 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