FDA.reportPublic FDA data

Nose It All

Primary DI
00860006794729
Brand
Nose It All
Company
Product Motif Inc.
Model
01-PN-016
Catalog number
01-PN-016
Device description
Single Pack Nosebleed Tourniquet Device - Large
Published
2022-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EMXBalloon, Epistaxis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMXBalloon, EpistaxisEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006794750PackageGS13In Commercial Distribution
00860006794729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006794750008600067947508600067947500860006794750
00860006794729008600067947298600067947290860006794729

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal splint, non-biodegradableA non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122314606
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860006794705Nose It All01-PN-01401-PN-0142022-04-05
00860006794712Nose It All01-PN-01501-PN-0152022-04-05
00860006794767Nose It All01-PN-02001-PN-0202022-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10855364004112Rhino-Pak 45mmMAR-MED INC.EMX2025-02-06
00855364004122Rhino-Pak 55mmMAR-MED INC.EMX2025-02-06
10855364004136Rhino-Pak 75mmMAR-MED INC.EMX2025-02-06
00821925030831Gyrus ACMIGyrus ACMI, LLCEMX2024-11-26
00821925022379Gyrus ACMIGyrus Acmi, Inc.EMX2024-07-25
30886158012222Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012239Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012246Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012253Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012260Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012284Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012291Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012314Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012321Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012338Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012345Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012352Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012369Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012376Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012383Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012390Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012406Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012437Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012444Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012451Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013243Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013267Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013274Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013281Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013298Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27