3.0 Liter Reservoir

GUDID 00896128002008

BELMONT INSTRUMENT CORPORATION

Heat-exchanging intravenous administration set Heat-exchanging intravenous administration set Heat-exchanging intravenous administration set Heat-exchanging intravenous administration set Heat-exchanging intravenous administration set Heat-exchanging intravenous administration set Heat-exchanging intravenous administration set Heat-exchanging intravenous administration set Heat-exchanging intravenous administration set Heat-exchanging intravenous administration set Heat-exchanging intravenous administration set Heat-exchanging intravenous administration set Heat-exchanging intravenous administration set Heat-exchanging intravenous administration set

Primary Device ID	00896128002008
NIH Device Record Key	c1cfa7d1-bbf2-4fa1-af61-403ea12385a9
Commercial Distribution Status	In Commercial Distribution
Brand Name	3.0 Liter Reservoir
Version Model Number	903-00018P
Company DUNS	078330362
Company Name	BELMONT INSTRUMENT CORPORATION
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896128002008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141654

FDA Product Code

LGZ	Warmer, Thermal, Infusion Fluid

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-12-11
Device Publish Date	2016-09-23

On-Brand Devices [3.0 Liter Reservoir]

10896128002005	903-00018
00896128002008	903-00018P