Straight In/Out Pt Line Kit

GUDID 00896128002213

w/ 4.4L Reservoir

BELMONT INSTRUMENT CORPORATION

Extravascular-circulation hyperthermia system applicator, intracorporeal
Primary Device ID00896128002213
NIH Device Record Key9e791b64-3be1-4e1d-b4f1-73b75b3f1b1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameStraight In/Out Pt Line Kit
Version Model Number902-00037
Company DUNS078330362
Company NameBELMONT INSTRUMENT CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100896128002213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGZWarmer, Thermal, Infusion Fluid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-01-15
Device Publish Date2016-09-23

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00896128002077 - Hyperthermia Pump St In/Out Pt Line2024-02-19
00896128002169 - Hyperthermia Pump St In/Out Pt Line2024-02-19
00896128002176 - Hyperthermia Pump Accessory2024-02-19
00896128002190 - Hyperthermia Pump Accessory2024-02-19
00896128002237 - Hyperthermia Pump St In/Out Pt Line Kit w/ 3L Reservoir2024-02-19

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