FDA.report

Rhinostics, Inc.

Primary DI
00850042963128
Brand
Rhinostics, Inc.
Company
Rhinostics Inc
Model
VS-S000001
Device description
VERIstic®
Published
2023-03-28
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
GIOTube, Collection, Capillary Blood

Product Code Classifications

CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850042963135PackageGS12016In Commercial Distribution
00850042963241PackageGS196In Commercial Distribution
00850042963258PackageGS196In Commercial Distribution
10850042963125PackageGS12000In Commercial Distribution
00850042963128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042963135008500429631358500429631350850042963135
00850042963241008500429632418500429632410850042963241
00850042963258008500429632588500429632580850042963258
1085004296312510850042963125
00850042963128008500429631288500429631280850042963128

GMDN Terms

TermDefinition
Capillary blood collection tube IVD, no additiveA glass or plastic collection tube containing no additive, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. 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
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 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
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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