AccessGUDID - DEVICE: Spinal Manometer (04048223069578)

GUDID

Device Identifier (DI) Information

Brand Name: Spinal Manometer
Version or Model: 001151-38G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001151-38G
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223069578
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: Spinal Manometer with three-way cock

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMJ	MANOMETER, SPINAL-FLUID

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170305	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 20 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5fb660cd-7bbd-44d7-9677-93eebeb8ffab
Public Version Date: February 07, 2025
Public Version Number: 1
DI Record Publish Date: January 30, 2025