K-Systems

GUDID 00888937025057

G85 Mini Incubator

Coopersurgical, Inc.

Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator
Primary Device ID00888937025057
NIH Device Record Keyc4ddee7d-5220-4584-9337-279e7ac89744
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-Systems
Version Model NumberK22074
Company DUNS801895244
Company NameCoopersurgical, 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937025057 [Primary]
GS100888937025057 [Primary]
GS100888937025057 [Primary]
GS100888937025057 [Primary]

FDA Product Code

PUBAccessory, Assisted Reproduction, Exempt
PUBAccessory, Assisted Reproduction, Exempt
PUBAccessory, Assisted Reproduction, Exempt
PUBAccessory, Assisted Reproduction, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [K-Systems]

00888937025071T47 Warming Plate
00888937025064T45 Warming Plate
00888937025057G85 Mini Incubator
00888937025040G73 Dry Bath Incubator
00888937025033G95 Mini Incubator
00888937025026R65 Trolley

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