FDA.reportPublic FDA data

Rhinostics, Inc.

Primary DI
00850042963012
Brand
Rhinostics, Inc.
Company
Rhinostics Inc
Model
LVL-1000001
Device description
Rhinostics Capped Transport Tube
Published
2023-09-18
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
NNIContainer, Specimen, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850042963012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042963012008500429630128500429630120850042963012

GMDN Terms#

Term, Definition table
TermDefinition
Specimen container mailer, non-insulatedA non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities and is intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
100216104
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850042963326Rhinostics, Inc.LVL-10000052024-05-24
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
00850042963043Rhinostics, Inc.RH-S0001112023-03-27
00850042963081Rhinostics, Inc.LV-2D1D0032023-03-27
00850042963104Rhinostics, Inc.LV-2D1D0022023-03-27
00850042963111Rhinostics, Inc.GW-UF1000012023-03-24

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