FDA.reportPublic FDA data

Apex

Primary DI
30076855700380
Brand
Apex
Company
COMPASS HEALTH BRANDS CORP.
Model
70036
Device description
Baby Nasal Aspirator
Published
2023-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30076855700380PackageGS172In Commercial Distribution
00076855700389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3007685570038030076855700380
00076855700389000768557003890768557003890076855700389

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
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
827221698
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
30194346615156Equate 72085EQ2026-01-20
40076855700608Apex70060BPKG2025-08-28
30023601200519AccuReliefACRL-00512025-07-17
30092237628561TENS 7000DT7308-ELEC42025-07-10
30092237628554TENS 7000DT7307-ELEC82025-06-30
30023601088209CarexFGE82000 00002025-06-25
30627394040019Pain CakesTMF70001CA2025-06-03
30627394040057Pain CakesTMF70005CA2025-06-03
30627394040064Pain CakesTMF70006CA2025-06-03
30023601017100CAREX HEALTH BRANDSFGA71000 00002025-05-21
30627394023036CarexFGB303CA2025-05-13
50023601023037CarexFGB30300 00002025-02-19
80092237626845TENS 7000DT73152025-01-21
30092237626734TENS 7000DT73092025-01-06
30092237626741TENS 7000DT73102025-01-06
30092237626758TENS 7000DT73142025-01-06
30632615880107Bed BuddyBBF8010-122024-12-18
30023601261008AccuReliefACRL-52002024-12-17
30041520865817Apex70010AHO2024-12-09
30635515992765Apex70010QC2024-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530095222Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00789091681557Adulat Soft CannulaSunset Healthcare Solutions, Inc.CAT2025-04-24
00789091681571Adulat Soft CannulaSunset Healthcare Solutions, Inc.CAT2025-04-24
00848530103866Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-06
00848530103873Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-06
00848530103880Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-06
00848530103897Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-06
00848530103903Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-06
00848530095871Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530095888Suction TubingSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530095895Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530095901Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530095918Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530095925Suction TubingSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530095932Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096038Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096045Suction TubingSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096052Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096069Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096076Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096083Suction TubingSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096090Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096700Closed SuctionSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096717Suction Tube ConnectorsSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096724Respiratory AccessorySunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096731Suction Tube ConnectorsSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096748Respiratory AccessorySunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096755Respiratory AccessorySunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096762Suction Tube ConnectorsSunset Healthcare Solutions, Inc.GCY2024-08-05
00848530096779Respiratory AccessorySunset Healthcare Solutions, Inc.GCY2024-08-05