i.Series Platelet Incubator

GUDID 00816394021688

Environmentatal chamber for storage of platelet concentrate

HELMER, INC.

Platelet incubator
Primary Device ID00816394021688
NIH Device Record Key10fb54a7-883e-4e6d-8f2c-46e68937dc74
Commercial Distribution StatusIn Commercial Distribution
Brand Namei.Series Platelet Incubator
Version Model NumberPC2200-Pro
Company DUNS086685682
Company NameHELMER, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816394021688 [Primary]

FDA Product Code

KSHChamber, Environmental For The Storage Of Platelet Concentrate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-09
Device Publish Date2022-12-01

On-Brand Devices [i.Series Platelet Incubator]

00816394021688Environmentatal chamber for storage of platelet concentrate
00816394021671Environmentatal chamber for storage of platelet concentrate

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