Carestation 620 1012-9620-000

GUDID 00840682103985

DATEX-OHMEDA INC

Anaesthesia workstation, general-purpose
Primary Device ID00840682103985
NIH Device Record Key2e5c3029-a397-4e7d-9517-d73f9ffd0bae
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarestation 620
Version Model NumberA1
Catalog Number1012-9620-000
Company DUNS129501685
Company NameDATEX-OHMEDA INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)345-2700
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682103985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSZGas-machine, anesthesia

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-02-12

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