DISPOSABLE XENON KITFOR NUCLEAR MEDICINE 20005

GUDID 00612649101903

XENON CIRCUIT

King Systems Corporation

Xenon administration system, diagnostic nuclear medicine Xenon administration system, diagnostic nuclear medicine Xenon administration system, diagnostic nuclear medicine
Primary Device ID00612649101903
NIH Device Record Key3b24802f-42e7-4872-bf0b-2001498a42b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDISPOSABLE XENON KITFOR NUCLEAR MEDICINE
Version Model Number20005
Catalog Number20005
Company DUNS009299017
Company NameKing Systems Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Customer Support Contacts

Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100612649101903 [Package]
Contains: 00612649185279
Package: [20 Units]
In Commercial Distribution
GS100612649185279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYTSystem, rebreathing, radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-21

On-Brand Devices [DISPOSABLE XENON KITFOR NUCLEAR MEDICINE]

00612649165769XENON CIRCUT 20/CS
00612649101903XENON CIRCUIT

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