FDA.reportPublic FDA data

PerkinElmer GRNK1 Card

Primary DI
00812589020016
Brand
PerkinElmer GRNK1 Card
Company
Perkinelmer, Inc.
Model
Dried Blood Spot Collection Card
Catalog number
GRNK1
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812589020948PrimaryGS10
00812589020955PrimaryGS10
00812589021105PrimaryGS10
00812589021112PrimaryGS10
00812589020016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812589020948008125890209488125890209480812589020948
00812589020955008125890209558125890209550812589020955
00812589021105008125890211058125890211050812589021105
00812589021112008125890211128125890211120812589021112
00812589020016008125890200168125890200160812589020016

GMDN Terms#

Term, Definition table
TermDefinition
Dried blood spot collection card IVDA device intended to be used for dried blood spot collection and preservation, at the point-of-care, for subsequent diagnostic testing or screening. It is typically in the form of paper integrated in a card, on which a whole blood specimen is applied and absorbed onto the collection paper. The card may include a form to capture patient demographic information This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968495627
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812589020078XRpad Digital X-Ray Detector SystemXRpad 4336 MED95510925-022016-07-29
00812589020085XRpad Digital X-Ray Detector SystemXRpad 4343 F MED95510935-022016-07-29
00812589020092XRpad Digital X-Ray Detector SystemXRpad2 4336 HWC-M955109812017-05-17
00812589020108XRpad Digital X-Ray Detector SystemXRpad2 3025 HWC-M955109912017-05-17
00812589020139XRpad Digital X-Ray Detector SystemXRpad LBC95510921H2016-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860013988029500 Single strip cards and 500 foil-LifelineADVANCE DX, INC.NNK2026-03-03
00860013988036500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
00860013988043Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988067Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
00860013988074Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
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00827989007789Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
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00810185250561TherapakTherapak LLCNNK2025-08-04
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00840216128729QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
00840216128736QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
04038917086318Urine receptacle 500mlSarstedt Aktiengesellschaft & Co.KGNNK2025-05-19
00860013899264Paternity Test Kit 50Ditek Consulting, LLCNNK2025-05-06
00860013899288Paternity Test Kit 25Ditek Consulting, LLCNNK2025-05-06
00860011770268Covid 19 Testing KitDitek Consulting, LLCNNK2025-05-01
00613647027059FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
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00613647027073FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
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