Identity
- Trade Name
- Apex FDA UDI
- Generic Name
- Irrigation syringe FDA UDI
- Device Name
- oral syringe FDA UDI
- Model / Reference
- 70004 FDA UDI
- Description
- oral syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00076855700044 FDA UDI
- FDA Product Code
- KYW FDA UDI
- GMDN Term
- Irrigation syringe FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6430 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Irrigation syringe
Apex by Compass Health Brands Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Irrigation syringe.
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- Medline — MEDLINE INDUSTRIES, INC. · Class I
- PROBEVAC — PLASDENT CORP. · Class I
- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- Monoject — Cardinalhealth · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Compass Health Brands Corp.
Sources (1)
- FDA UDI 1a3e5cec-1960-4e58-959a-4bd931e87ae0 34 fields · synced May 30, 2026