FDA.report

Apex

Primary DI
30076855700236
Brand
Apex
Company
COMPASS HEALTH BRANDS CORP.
Model
70023
Device description
Oral Syrine With Adaptor
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

Related Records

Contact Domains

Product Codes

CodeName
KYWContainer, Liquid Medication, Graduated

Product Code Classifications

CodeDeviceSpecialtyClass
KYWContainer, Liquid Medication, GraduatedGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30076855700236PackageGS1144In Commercial Distribution
00076855700235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3007685570023630076855700236
00076855700235000768557002350768557002350076855700235

GMDN Terms

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

Contacts

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
true
No natural rubber latex
false
Sterilization required before use
false

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00092237902257MicroBlock Antimicrobial Electrode400-877-MIC2020-06-11
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00092237902288MicroBlock Antimicrobial Electrode400-852-MIC2020-06-11
00092237902264MicroBlock Antimicrobial Electrode400-879-MIC2020-06-11
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80827989007938Health Care Logistics, Inc®Health Care Logistics, Inc.KYW2026-02-09
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06931918145061AllesetGRI Medical & Electronic Technology Co., Ltd.KYW2025-06-20
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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
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