FDA.reportPublic FDA data

Salimetrics

Primary DI
00859410006306
Brand
Salimetrics
Company
SALIMETRICS, LLC
Model
N/A
Catalog number
5004.02
Device description
Salimetrics Cryovial, Blue 25/pk
Published
2024-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
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
00859410006306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859410006306008594100063068594100063060859410006306

GMDN Terms#

Term, Definition table
TermDefinition
Oral/respiratory tract specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
084843064
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
00859410006351SalimetricsN/A5016.042025-12-10
00859410006368SalimetricsN/A5016.04B2025-12-10
00859410006375SalimetricsN/A5001.022025-12-10
00859410006344SalivaBioN/A5001.06B2025-11-24
00859410006283SalimetricsN/A5004.012024-12-27
00859410006290SalimetricsN/A5004.042024-12-27
00859410006313SalimetricsN/A5004.032024-12-27
00859410006320SalimetricsN/A5004.062024-12-27
00859410006337SalimetricsN/A5004.052024-12-27
00859410006269SalimetricsN/A1-44102024-09-18
00859410006276SalimetricsN/A1-4410-52024-09-18
00859410006245SalimetricsN/A1-3512-52023-09-26
00859410006252SalimetricsN/A1-35122023-09-26
00859410006139SalimetricsN/A1-23122022-08-23
00859410006177SalimetricsN/A1-2312-52022-08-23
00859410006009SalivaBioN/A5016.042022-10-13
00859410006214SalivaBioN/A5016.04B2022-10-13
00859410006221SalivaBioN/A5016.062022-10-13
00859410006238SalivaBioN/A5016.06B2022-10-13
00859410006184SalivaBioN/A5001.082022-10-13

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Primary DI, Brand, Company table
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00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
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00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
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