FDA.reportPublic FDA data

Apex

Primary DI
30076855700083
Brand
Apex
Company
COMPASS HEALTH BRANDS CORP.
Model
70008
Device description
Oral Syringe - Small - Carded
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
KYWContainer, Liquid Medication, Graduated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYWContainer, Liquid Medication, GraduatedGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30076855700083PackageGS1144In Commercial Distribution
00076855700082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3007685570008330076855700083
00076855700082000768557000820768557000820076855700082

GMDN Terms#

Term, Definition table
TermDefinition
Medication cartridge syringe, needleless, single-useA sterile device designed to be used in conjunction with a hermetically-sealed glass cartridge containing medication (not included) to propel the contents of the cartridge across the skin (transcutaneous delivery) and into the subcutaneous tissue (needleless) when used in combination with an injector (not included). It consists of a breech-loading barrel, plunger and specialized nozzle. This is a single-use 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
00092237613269Roscoe MedicalLS52662016-10-13
00194346678921Equate73085EQ2026-03-09
00714905117649Fab StimDT30252026-02-06
00714905710024Fab StimDT70252026-02-06
00860163000312CMS DT30292026-02-06
00092237622209SCRIPHESSCO672-0192-CH2026-02-03
00092237622216SCRIPHESSCO672-0193-CH2026-02-03
00092237622339SCRIPHESSCO672-0195-CH2026-02-03
30194346615156Equate 72085EQ2026-01-20
00092237627495Roscoe MedicalO2C6P2026-01-15
00023601130402CarexFGB30400 00002025-12-01
00092237622193SCRIPHESSCO672-0010-CH2025-11-24
00714905710062FabStimE1P3000TC2FS2025-11-18
00092237621967TwinStimDS5002-OTC2025-09-29
00092237902257MicroBlock Antimicrobial Electrode400-877-MIC2020-06-11
00092237902240MicroBlock Antimicrobial Electrode400-872-MIC2019-01-08
00092237902288MicroBlock Antimicrobial Electrode400-852-MIC2020-06-11
00092237902264MicroBlock Antimicrobial Electrode400-879-MIC2020-06-11
00092237902271MicroBlock Antimicrobial Electrode400-881-MIC2020-06-11
00092237611531Roscoe MedicalLS52552016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
80827989007907Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007914Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007921Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
80827989007938Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
30815112021444Mixing ContainerBracco Diagnostics Inc.KYW2026-01-09
00194613039127MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-08-01
00194613046330MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-08-01
00194613096502MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-08-01
00194613121082MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-08-01
06931918145061AllesetGRI Medical & Electronic Technology Co., Ltd.KYW2025-06-20
10661392002187LSL HEALTHCARELSL Industries, LLCKYW2025-05-16
10661392012339LSL HEALTHCARELSL Industries, LLCKYW2025-05-16
00194613096519MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-03-21
00194613122669MSI Precision Specialty InstrumentsMed Saver, Inc.KYW2025-03-21
10827989000268Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-03-13
10827989003627Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-03-13
20827989003464Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
20827989003471Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
20827989003488Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
20827989003495Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2025-01-08
00840306835964Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-12-11
00810180844918Medicine Cups 1oz Dynarex CorporationKYW2024-10-28
00840117341210Medicine Cups 1oz Dynarex CorporationKYW2024-10-28
00840306835926Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-10-22
00840306835957Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-10-22
00840306835971Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-10-22
00840306835995Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-10-22
00840306836015Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KYW2024-10-22
00653160381467MEDLINEMEDLINE INDUSTRIES, INC.KYW2024-10-18
00840216128033ASP MEDICALAsp Global, LLCKYW2024-09-12