AccessGUDID - DEVICE: Manifold, 2 + 2, Wall Alarm, No Regs Or Hoses (00813830021912)

GUDID

Device Identifier (DI) Information

Brand Name: Manifold, 2 + 2, Wall Alarm, No Regs Or Hoses
Version or Model: 34064
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 34064
Company Name: ACCUTRON, INC.

Primary DI Number: 00813830021912
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 088302096 *Terms of Use

Device Description: No description.

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?
44807	Medical gas pipeline system	An assembly of devices designed to supply compressed medical gases [e.g., oxygen (O2), nitrous oxide (N2O), medical air, surgical-grade air] from a central source to endpoints throughout a medical facility. The system typically consists of several gas supplies (bulk gas, bottled gas with air compressors), a pipework system that includes pressure regulators, pressure relief valves, zone valves, an alarm system with remote or local indicators, emergency backup devices for essential gases, and wall outlet/inlet terminal units.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXH	Gauge, Gas Pressure, Cylinder/Pipeline

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: baa02c63-b01a-414b-b064-093b329947aa
Public Version Date: August 01, 2023
Public Version Number: 3
DI Record Publish Date: September 27, 2016