FRU, Vacuum Tubing 6' 27132

GUDID 00813830020922

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer Oxygen/air/nitrous oxide breathing gas mixer Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger

Primary Device ID	00813830020922
NIH Device Record Key	6fcd48d1-1d48-4b79-9868-dc4a3e4c765d
Commercial Distribution Status	In Commercial Distribution
Brand Name	FRU, Vacuum Tubing 6'
Version Model Number	27132
Catalog Number	27132
Company DUNS	088302096
Company Name	ACCUTRON, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813830020922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K033503

FDA Product Code

CBN	Apparatus, Gas-Scavenging

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-28