WHALE

GUDID 06970528550025

Beijing East Whale Imaging Technology Co.,Ltd.

Mobile general-purpose fluoroscopic x-ray system, digital
Primary Device ID06970528550025
NIH Device Record Key244e42a1-d193-47f1-b966-802c3120af40
Commercial Distribution StatusIn Commercial Distribution
Brand NameWHALE
Version Model NumberDigiArc 100AU+
Company DUNS529847741
Company NameBeijing East Whale Imaging Technology Co.,Ltd.
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

Device Dimensions

Weight600 Kilogram
Width922 Millimeter
Length2234 Millimeter
Height2540 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS106970528550025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAASystem, X-Ray, Fluoroscopic, Image-Intensified

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 Date2016-09-04

On-Brand Devices [WHALE]

06970528550063B6
06970528550056P9
06970528550049P7
06970528550032P5
06970528550025DigiArc 100AU+
06970528550018DigiArc 100AU

Trademark Results [WHALE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WHALE
WHALE
98011851 not registered Live/Pending
Ireti Inc.
2023-05-24
WHALE
WHALE
98011832 not registered Live/Pending
Ireti Inc.
2023-05-24
WHALE
WHALE
97899903 not registered Live/Pending
ZhiZhao
2023-04-21
WHALE
WHALE
90684203 not registered Live/Pending
Thomas William McGrath
2021-04-30
WHALE
WHALE
88747556 not registered Live/Pending
Shanghai Protop Merchant Co., Ltd
2020-01-06
WHALE
WHALE
88196162 not registered Live/Pending
Whale Limited
2018-11-15
WHALE
WHALE
86602958 4904110 Live/Registered
SHENZHEN PENGYIFA PRECISION MOULDS LIMITED
2015-04-20
WHALE
WHALE
86108542 not registered Dead/Abandoned
Alpine Beer Company, Inc.
2013-11-01
WHALE
WHALE
85732710 4886211 Live/Registered
Munster Simms Engineering Ltd.
2012-09-19
WHALE
WHALE
85664915 4355400 Live/Registered
BEIJING EAST WHALE IMAGE TECHNOLOGY CO.,LTD.
2012-06-29
WHALE
WHALE
79104692 not registered Dead/Abandoned
VEE DEE PTE Limited
2011-10-21
WHALE
WHALE
79006684 3112168 Live/Registered
Munster Simms Engineering Limited
2004-03-29

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