FDA.reportPublic FDA data

Rhinostics, Inc.

Primary DI
00850042963043
Brand
Rhinostics, Inc.
Company
Rhinostics Inc
Model
RH-S000111
Device description
RHINOstic® Automated Swab
Published
2023-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXGApplicator, Absorbent Tipped, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXGApplicator, Absorbent Tipped, SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850042963050PackageGS12016In Commercial Distribution
00850042963067PackageGS12000In Commercial Distribution
00850042963203PackageGS196In Commercial Distribution
00850042963210PackageGS196In Commercial Distribution
00850042963043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042963050008500429630508500429630500850042963050
00850042963067008500429630678500429630670850042963067
00850042963203008500429632038500429632030850042963203
00850042963210008500429632108500429632100850042963210
00850042963043008500429630438500429630430850042963043

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection swabA 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 culture, analysis, and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
100216104
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850042963326Rhinostics, Inc.LVL-10000052024-05-24
00850042963012Rhinostics, Inc.LVL-10000012023-09-18
00850042963074Rhinostics, Inc.LVL-10000022023-09-18
00850042963098Rhinostics, Inc.LVL-10000032023-09-18
00850042963128Rhinostics, Inc.VS-S0000012023-03-28
00850042963142Rhinostics, Inc.HS-S0000012023-03-28
00850042963005Rhinostics, Inc.PG-1000012023-03-27
00850042963081Rhinostics, Inc.LV-2D1D0032023-03-27
00850042963104Rhinostics, Inc.LV-2D1D0022023-03-27
00850042963111Rhinostics, Inc.GW-UF1000012023-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
58053326007021FLOQSwabs®COPAN ITALIA SPAKXG2026-03-20
10197344169214CARINGMEDLINE INDUSTRIES, INC.KXG2025-12-05
00840456216675JMUJMU DENTAL, INCKXG2025-11-12
00840456216682JMUJMU DENTAL, INCKXG2025-11-12
M220767003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
M220768003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
M220768013Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
00840456214916JMUJMU DENTAL, INCKXG2025-07-15
00840456214923JMUJMU DENTAL, INCKXG2025-07-15
58053326011653CLASSIQSwabCOPAN ITALIA SPAKXG2025-07-03
58053326011660CLASSIQSwabs™ FLOQ Swabs® COPAN ITALIA SPAKXG2025-07-03
00842558116402BactiSwab Dry PK/100REMEL, INC.KXG2025-06-19
00810180840958LabChoice Transport Swabs, Wooden Shaft, Cotton Tip, Sterile Dynarex CorporationKXG2025-02-28
00810180840965LabChoice Transport Swabs, Wooden Shaft, Viscose Tip, SterileDynarex CorporationKXG2025-02-28
00810180840972LabChoice Transport Swabs, Snappable Polystyrene Shaft, Cotton Tip, Sterile Dynarex CorporationKXG2025-02-28
00840117329706LabChoice Transport Swabs, Snappable Polystyrene Shaft, Viscose Tip, SterileDynarex CorporationKXG2025-02-28
00840165400372Starswab Dry SwabPretium Canada Packaging ULCKXG2025-02-21
00840165400396Starswab Dry SwabPretium Canada Packaging ULCKXG2025-02-21
05060166524524Oracol MALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
05060166525743Oracol SwabMALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
05060166524531Oracol+MALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
58053326011684FLOQSwabs® COPAN ITALIA SPAKXG2024-12-18
00603266511848Super BrushSuper Brush, LLCKXG2024-08-30
10603266530839Super BrushSuper Brush, LLCKXG2024-08-30
10603266531874Super BrushSuper Brush, LLCKXG2024-08-30
10603266533830Super BrushSuper Brush, LLCKXG2024-08-30
10603266534875Super BrushSuper Brush, LLCKXG2024-08-30
10603266541835Super BrushSuper Brush, LLCKXG2024-08-30
00842558116501BactiSwab (Dry) CS/500Remel Inc.KXG2024-08-14
58053326011509FLOQSwabs® COPAN ITALIA SPAKXG2024-07-02