FDA.reportPublic FDA data

Salimetrics

Primary DI
00859410006375
Brand
Salimetrics
Company
SALIMETRICS, LLC
Model
N/A
Catalog number
5001.02
Device description
Salimetrics Oral Swab (SOS) PK/50
Published
2025-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FRLFiber, Medical, Absorbent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859410006375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859410006375008594100063758594100063750859410006375

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection swab IVDAn in vitro diagnostic device in the form of a piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for in vitro diagnostic investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
084843064
Device count
1
Kit
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
00859410006344SalivaBioN/A5001.06B2025-11-24
00859410006283SalimetricsN/A5004.012024-12-27
00859410006290SalimetricsN/A5004.042024-12-27
00859410006306SalimetricsN/A5004.022024-12-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536925007BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925014BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925021BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925038BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925045BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925052BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925069BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925076BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925083BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925090BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925106BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925113BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925120BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925137BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925144BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925151BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925168BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
20197344219428MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219442MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219459MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219466MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219473MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219480MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219497MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219503MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219435MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-13
10814707025023CygnusASPEN SURGICAL PRODUCTS, INC.FRL2026-04-10
10850018327982MHMazza Healthcare LLCFRL2026-04-09
10193489001907MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-08-06
10653160341628CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFRL2025-07-06