FDA.reportPublic FDA data

Innovo

Primary DI
00851697006024
Brand
Innovo
Company
Innovo Medical
Model
ZBH-BULB
Catalog number
B370N-AACL-JPIM
Device description
Cleanable and reusable nasal bulb aspirator
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851697006024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851697006024008516970060248516970060240851697006024

GMDN Terms#

Term, Definition table
TermDefinition
Nasal aspirator, manualA portable, hand-held, manual suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It is available in a variety of forms including a compressible bulb with a tube that is inserted into the nares, or a syringe with a small bulb at its distal end that is applied to the nasal opening. It is designed for domestic use. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8588889781cs@innovogroups.com

Regulatory Flags#

DUNS number
080053362
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851697006000Innovo430J/PEM430N-PEWH-JPIM2017-03-14
00851697006048InnovoCMS 50F PlusCMS50FPLUSBT2016-09-23
00851697006123Innovo430C/DL-PEM430N-CEWH-CMIM2016-09-23
00851697006178InnovoiP900APM430N-PEWH-JPIM2017-10-30
00851697006253Innovom900BPM430N-CPWH-CMIM2018-07-30
00851697006062InnovoiSoothe E-946R-5E-946R-52016-09-23
00851697006192InnovoJapanese Gel - 4 piecesM946N-04WH-TRIM2017-10-30
00851697006208InnovoJapanese Gel - 44 piecesM946N-44WH-TRIM2017-10-30
00851697006222InnovoiT300AG-SM942N-GSWH-DDIM2018-08-31
00851697006239InnovoiT300AG-LM942N-GLWH-DDIM2018-08-31
00851697006093InnovoINV-EF10010499EF2016-09-23
00851697006130InnovoINV-FR201M499N-F1WH-JPIM2016-11-22
00851697006154InnovoINV-EF100499EFv22017-01-06
00851697006185InnovoINV-EF100M499N-E2SI-JPIM2017-03-31
00851697006031InnovoiSoothe INV-942R942R-O2016-09-23
00851697006215InnovoiT300ABM942N-WBWH-DDIM2018-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956231788CARDINAL HEALTHCardinal Health 200, LLCGCY2025-10-20
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50192253042748ArgyleCardinal Health 200, LLCGCY2025-10-02
50192253042755ArgyleCardinal Health 200, LLCGCY2025-10-02
10198956012769CARDINAL HEALTHCardinal Health 200, LLCGCY2025-03-26
10197106675588CARDINAL HEALTHCardinal Health 200, LLCGCY2024-05-22
10197106600788CARDINAL HEALTHCardinal Health 200, LLCGCY2024-03-25
00630094061504Bioseal Inc.BIOSEALGCY2024-01-29
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00630094061528Bioseal Inc.BIOSEALGCY2024-01-29
00630094049175Bioseal Inc.BIOSEALGCY2024-01-25
10197106520932CARDINAL HEALTHCardinal Health 200, LLCGCY2024-01-24
00630094049052Bioseal Inc.BIOSEALGCY2024-01-24
00630094049168Bioseal Inc.BIOSEALGCY2024-01-24
00630094043807Bioseal Inc.BIOSEALGCY2024-01-19
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00630094196961Bioseal Inc.BIOSEALGCY2023-11-29
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