Voluson

GUDID 00840682100137

GE Healthcare Austria GmbH & Co OG

General-purpose ultrasound imaging system
Primary Device ID00840682100137
NIH Device Record Keyb07a9d4d-dc2e-409e-918c-7bcb9d6040a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameVoluson
Version Model NumberE8 BT16
Company DUNS300599979
Company NameGE Healthcare Austria GmbH & Co OG
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 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)437-1171
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682100137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

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 Date2016-08-01

On-Brand Devices [Voluson]

00840682145411E BT19 to BT20 UPG
00840682144353E10 BT20
00840682144346VE8 BT20
00840682144339E6 BT20
00840682142588E BT17 to BT19 UPG
00840682139533E BT18 to BT19 UPG
00840682139168VE8 BT19
00840682139151E10 BT19
00840682139144E6 BT19
00840682123945E8 BT18
00840682123938E10 BT18
00840682123907E6 BT18
00840682123891E BT17 to BT18 UPG
00840682120661E BT16 to BT17 UPG
00840682120197E BT15 to BT17 UPG
00840682119672ie all BTs to BT14 UPG
00840682118712E BT10 to BT13 UPG
00840682118705E BT15 to BT16 UPG
00840682118675E BT12 to BT13 UPG
00840682117951E10 BT17
00840682117944E8 BT17
00840682117937E6 BT17
00840682100144E10 BT16
00840682100137E8 BT16
00840682100120E6 BT16
00195278077592E BT20 to BT21 UPG
00195278016836E6 BT21
00195278016829E8 BT21
00195278016812E10 BT21
00195278347497Voluson Expert 22
00195278347480Voluson Expert 20
00195278347473Voluson Expert 18
00195278699824Voluson Expert 20 BT24
00195278699800Voluson Expert 18 BT24
00195278699848Voluson Expert 22 BT24
00195278677587Voluson Exp to BT24 UPG

Trademark Results [Voluson]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VOLUSON
VOLUSON
74049572 1687722 Live/Registered
KRETZTECHNIK AKTIENGESELLSCHAFT
1990-04-16

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