Spinal Manometer

Basic Information

• Brand Name: Spinal Manometer
• Primary DI: 04048223069578
• Version / Model: 001151-38G
• Catalog Number: 001151-38G
• Company Name: Pajunk GmbH Medizintechnologie
• Labeler DUNS: 317654283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-30
• Public Version: 1
• Public Version Date: 2025-02-07
• Public Version Status: New
• Public Device Record Key: 5fb660cd-7bbd-44d7-9677-93eebeb8ffab

Device Description

Spinal Manometer with three-way cock

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMJ	MANOMETER, SPINAL-FLUID	General Hospital	880.2500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43668	Cerebrospinal fluid manometer, mechanical	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04048223048986	GS1		10	In Commercial Distribution
Primary	04048223069578	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K170305	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 65 Percent (%) Relative Humidity