FDA.reportPublic FDA data

N/A

Primary DI
00810047421009
Brand
N/A
Company
Scientific Device Laboratory, Inc.
Model
615-5
Device description
Paraclear [5 gallon - each]
Published
2023-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KEMAgent, Clearing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEMAgent, ClearingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810047421009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810047421009008100474210098100474210090810047421009

GMDN Terms#

Term, Definition table
TermDefinition
Reagent grade alcohol solution IVDA reagent grade alcohol solution (e.g., methanol, ethanol, isopropanol) intended to be used as a dehydrant in the processing of biological tissues or clinical specimens.

Regulatory Flags#

DUNS number
115927956
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810047422075N/A49452024-08-08
00810047420293N/A7452023-01-30
00810047420323N/A7532023-01-30
00810047421061N/A745-12023-01-31
00810047422068N/A345-1002024-07-11
00810047422051N/A5152024-04-17
00810047422044N/A5202024-04-04
00810047422037N/A4912024-02-28
00810047422013N/A495-32024-01-09
00810047422020N/A4852024-01-09
00810047421993N/A5222023-09-21
00810047422006N/A5122023-09-21
00810047421986N/A373-C2023-08-31
00810047421832Scientific Device Laboratory6442023-08-14
00810047421962N/A4602023-06-12
00810047421979N/A4902023-06-12
00810047421863N/A6602023-06-08
00810047421870N/A4552023-06-08
00810047421887N/A3532023-06-08
00810047421894N/A353-A2023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50885380043268CARDINAL HEALTHCardinal Health 200, LLCKEM2026-01-06
10885380043260CARDINAL HEALTHCardinal Health 200, LLCKEM2026-01-06
00613647028438FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
00613647028506FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
00613647028513FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
00613647028636FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
20613647028432FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
20613647028500FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
20613647028517FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
20613647028630FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEM2025-04-30
00673693086974EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693087032EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693088923EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693101561EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693101592EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693101608EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693228374EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693236102EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693236133EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693236140EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693476126EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693556736EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693755078EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693755085EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693755115EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-23
00673693087025EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-22
00673693476133EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEM2024-07-22
00810047420583N/AScientific Device Laboratory, Inc.KEM2023-01-31
00810047420989N/AScientific Device Laboratory, Inc.KEM2023-01-31
00810047420996N/AScientific Device Laboratory, Inc.KEM2023-01-31