PerkinElmer 226

GUDID 20812589020010

Perkinelmer, Inc.

Blood collection paper Blood collection paper Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD Dried blood spot collection card IVD
Primary Device ID20812589020010
NIH Device Record Keya68cce97-a9d3-431e-aa67-28a7305bde87
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerkinElmer 226
Version Model NumberNewborn Screening Card
Company DUNS968495627
Company NamePerkinelmer, Inc.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812589020016 [Unit of Use]
GS120812589020010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PJCNewborn Screening Specimen Collection Paper

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 Date2016-08-29

On-Brand Devices [PerkinElmer 226]

60812589020018Newborn Screening Card
50812589020011Newborn Screening Card
40812589020014Newborn Screening Card
30812589020017Newborn Screening Card
20812589020010Newborn Screening Card

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