HemoSphere HEMRLSTD1000

GUDID 00690103197105

HemoSphere Roll Stand

Edwards Lifesciences LLC

Medical monitor/light stand
Primary Device ID00690103197105
NIH Device Record Keyff42f82e-ad61-48d1-b9b2-149c90b1228e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHemoSphere
Version Model NumberHEMRLSTD1000
Catalog NumberHEMRLSTD1000
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exempttrue
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

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103197105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQECatheter, Oximeter, Fiberoptic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-23
Device Publish Date2017-07-24

On-Brand Devices [HemoSphere]

00690103199321Pressure Cable
00690103197105HemoSphere Roll Stand
00690103197006HemoSphere Advanced Monitor
00690103196993HemoSphere Swan-Ganz Module
00690103196986HemoSphere Oximetry Cable
00690103199338DPT OUT CABLE
00690103202762CLEARSIGHT MODULE

Trademark Results [HemoSphere]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEMOSPHERE
HEMOSPHERE
86899593 5336032 Live/Registered
Edwards Lifesciences Corporation
2016-02-05
HEMOSPHERE
HEMOSPHERE
77402811 3686885 Dead/Cancelled
CRYOLIFE, INC.
2008-02-21
HEMOSPHERE
HEMOSPHERE
74429309 2081831 Dead/Cancelled
Hemosphere, Inc.
1993-08-25

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