FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NNIContainer, Specimen, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850042963012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042963012008500429630128500429630120850042963012

GMDN Terms

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

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
false
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 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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