SalivaBio

Primary DI
00859410006009
Brand
SalivaBio
Company
SALIMETRICS, LLC
Model
N/A
Catalog number
5016.04
Device description
SalivaBio Saliva Collection Aid PK/50
Published
2022-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859410006009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859410006009008594100060098594100060090859410006009

GMDN Terms#

Term, Definition table
TermDefinition
Saliva collection mouthpiece IVDA hand-held intraoral device intended to be used by a layperson in the home to help with the self-collection of a saliva/oral fluid specimen (passive drool) for diagnostic testing or screening purposes (e.g., COVID-19 test). It is in the form of a tubular mouthpiece inserted between the lips to help the patient guide saliva into a collection receptacle (not included) at the distal end. 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

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
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
00859410006214SalivaBioN/A5016.04B2022-10-13
00859410006221SalivaBioN/A5016.062022-10-13
00859410006238SalivaBioN/A5016.06B2022-10-13
00859410006184SalivaBioN/A5001.082022-10-13