FDA.reportPublic FDA data

Revvity 226

Primary DI
50812589020011
Brand
Revvity 226
Company
Revvity, Inc.
Model
Newborn Screening Card
Published
2016-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PJCNewborn Screening Specimen Collection Paper

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJCNewborn Screening Specimen Collection PaperClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121864000PERKINELMER 226 SAMPLE COLLECTION DEVICESPerkinelmer, Inc.2013-03-12PJC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50812589020011PrimaryGS10
00812589020016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081258902001150812589020011
00812589020016008125890200168125890200160812589020016

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection paperA non-sterile filter-paper card intended to be used as a medium for the collection and transport of blood specimen spots to a laboratory for testing. It provides a uniform surface for the collection of blood spot specimens taken from the patient. Also known as an Ahlstrom 226 specimen collection paper or a Whatman body fluid collection paper, it may incorporate a tear-apart form for demographic information. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968495627
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812589020948PerkinElmer GRNK1 CardDried Blood Spot Collection CardGRNK12022-09-23
00812589020955PerkinElmer GRNK1 CardDried Blood Spot Collection CardGRNK12022-09-23
20812589020010Revvity 226Newborn Screening Card2016-08-29
30812589020017Revvity 226Newborn Screening Card2016-08-29
40812589020014Revvity 226Newborn Screening Card2016-08-29
60812589020018Revvity 226Newborn Screening Card2016-08-29
00812589021105Revvity GRNK1 CardDried Blood Spot Collection CardGRNK12023-08-17
00812589021112Revvity GRNK1 CardDried Blood Spot Collection CardGRNK12023-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870021294903 DBS Collection Cards - 6 SamplesMONOBIND, INC.PJC2024-09-13
00816870021300903 DBS Collection Cards - 5 SamplesMONOBIND, INC.PJC2024-09-13
20812589020010Revvity 226Revvity, Inc.PJC2016-08-29
30812589020017Revvity 226Revvity, Inc.PJC2016-08-29
40812589020014Revvity 226Revvity, Inc.PJC2016-08-29
60812589020018Revvity 226Revvity, Inc.PJC2016-08-29