AtriCure System Cart A000951

GUDID 00818354014754

Fusion Cart

ATRICURE, INC.

Instrument trolley
Primary Device ID00818354014754
NIH Device Record Key08a13103-b814-4b78-9238-9af0976b547c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtriCure System Cart
Version Model NumberASCF
Catalog NumberA000951
Company DUNS006133784
Company NameATRICURE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-349-2342
Emailxxx@xxx.xxx
Phone866-349-2342
Emailxxx@xxx.xxx

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100818354014754 [Primary]

FDA Product Code

HMFStand, Instrument, Ac-Powered, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-22
Device Publish Date2018-09-21

On-Brand Devices [AtriCure System Cart ]

00818354014754Fusion Cart
00818354011920CRYO CART KIT ASSEMBLY - TWO TANK SUPPORTS
00818354011906Basic Cart
00818354011869Simple Cart
00818354011760PACKAGED CRYO CART
00818354011746PACKAGED ORLAB CART KIT ASSEMBLY
00818354011722PACKAGED CRYO CART KIT ASSEMBLY - SINGLE TANK
00818354011708Cable Kit, Basic Cart
00818354011685Basic Cart
00818354011128COMPACT CART 450 INSTALLATION KIT
00818354010978ORLab Touch Screen Pkg
00818354010954COMPACT CART INSTALLATION KIT
00818354016451ASCC-400 Tool and IFU Kit
00818354016444ASCB Installation Tools and Hardware Kit
30840143902127CRYO CART KIT ASSEMBLY - TWO TANK SUPPORTS
10840143901676PACKAGED ORLAB CART KIT ASSEMBLY
10840143901546Fusion Cart
30840143903438Basic Cart
10840143901515Simple Cart
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