AccessGUDID - DEVICE: IRRAflow Tube Set (00850013266203)

GUDID

Device Identifier (DI) Information

Brand Name: IRRAflow Tube Set
Version or Model: ICDS 030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ICDS 030
Company Name: Irras USA, Inc.

Primary DI Number: 00850013266203
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056999617 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
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?
62640	Cerebrospinal fluid pressure regulation system, gravity-flow	An assembly of electronic devices designed to simultaneously monitor cerebrospinal fluid (CSF) pressure and drain CSF at a rate regulated by the desired intracranial or in-tube CSF pressure. It consists of a control unit, a user interface, and provides CSF drainage via gravity; it is connected to disposable tubing/collection bags and a dedicated CSF access device (e.g., catheter, needle) inserted into the cerebral ventricles or subarachnoid (intrathecal) space of the spinal column. It is typically used in head trauma, normal pressure hydrocephalus (NPH) diagnostics, and during major vascular surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	Device, Monitoring, Intracranial Pressure
JXG	Shunt, Central Nervous System And Components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Temperature: between -25 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 73a1ca01-750c-45b1-b619-4c4767b38355
Public Version Date: June 11, 2024
Public Version Number: 2
DI Record Publish Date: November 02, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10850013266200	5	00850013266203		In Commercial Distribution	Box
00850013266265	1	00850013266203		In Commercial Distribution	Each

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-213-4604
Email: info@irras.com

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