Home GUDID 00850042963005 Rhinostics, Inc.
Primary DI 00850042963005
Brand Rhinostics, Inc.
Company Rhinostics Inc
Model PG-100001
Device description Rhinostics Standard Swab
Published 2023-03-27
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 Code Name KXG Applicator, Absorbent Tipped, Sterile
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KXG Applicator, Absorbent Tipped, Sterile General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850042963029 Package GS1 2016 In Commercial Distribution 00850042963036 Package GS1 2000 In Commercial Distribution 00850042963180 Package GS1 96 In Commercial Distribution 00850042963197 Package GS1 96 In Commercial Distribution 00850042963005 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850042963029 00850042963029 850042963029 0850042963029 00850042963036 00850042963036 850042963036 0850042963036 00850042963180 00850042963180 850042963180 0850042963180 00850042963197 00850042963197 850042963197 0850042963197 00850042963005 00850042963005 850042963005 0850042963005
GMDN Terms# Term, Definition table Term Definition General specimen collection kit IVD, home-use A collection of devices intended to be used by a layperson in the home for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula, cup], and a covered specimen receptacle(s) with or without an additive/medium (e.g., preservation solution, microbiological medium) and mailing packing/envelope. It may include other relevant devices (e.g., a lancet). This is a single-use device.
Regulatory Flags# DUNS number 100216104 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 DI Brand Model Catalog Published 00850042963326 Rhinostics, Inc. LVL-1000005 2024-05-24 00850042963012 Rhinostics, Inc. LVL-1000001 2023-09-18 00850042963074 Rhinostics, Inc. LVL-1000002 2023-09-18 00850042963098 Rhinostics, Inc. LVL-1000003 2023-09-18 00850042963128 Rhinostics, Inc. VS-S000001 2023-03-28 00850042963142 Rhinostics, Inc. HS-S000001 2023-03-28 00850042963043 Rhinostics, Inc. RH-S000111 2023-03-27 00850042963081 Rhinostics, Inc. LV-2D1D003 2023-03-27 00850042963104 Rhinostics, Inc. LV-2D1D002 2023-03-27 00850042963111 Rhinostics, Inc. GW-UF100001 2023-03-24
Other Devices Sharing Product Codes#