AccessGUDID - DEVICE: 2530 BALLOON CONTROLLER (00817136026022)

GUDID

Device Identifier (DI) Information

Brand Name: 2530 BALLOON CONTROLLER
Version or Model: 2530
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CR2006
Company Name: HANS RUDOLPH, INC.

Primary DI Number: 00817136026022
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 007131725 *Terms of Use

Device Description: 2530 INFL-3 BAL CNTRL 25' TUBING

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:	No
Prescription Use (Rx):	Yes
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?
37068	Pulmonary function valve	A non-sterile, dedicated valve intended to be used with a parent device for the measurement/analysis of a patient's pulmonary function. It is typically used to control inspired/expired gas directional flow and assist in the inhalation and distribution of test gases. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYX	Tubing, Pressure And Accessories

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0aeba521-fc33-48bf-88b3-a025b5c725ea
Public Version Date: June 30, 2023
Public Version Number: 3
DI Record Publish Date: January 04, 2019