Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Metered-delivery hypodermic syringe FDA UDI
- Device Name
- 35 mL Syringe,Luer-Lock Tip FDA UDI
- Model / Reference
- 1183500777 FDA UDI
- Description
- 35 mL Syringe,Luer-Lock Tip FDA UDI
Identifiers
- Catalog Number
- 1183500777 FDA UDI
- Primary DI / UDI-DI
- 10884521010826 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Metered-delivery hypodermic syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 35 Milliliter FDA UDI
Category: Metered-delivery hypodermic syringe
Monoject by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metered-delivery hypodermic syringe.
- TERUMO — Terumo (Philippines) Corporation · Class II
- SURGUARD2 — Terumo (Philippines) Corporation · Class II
- ZevRx STERILE INSULIN SYRINGE 5/16” | 1/2CC | 30G — HOME AIDE DIAGNOSTICS, INC. · Class II
- Syringe with needle — ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD · Class II
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
- Wealy® RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
- Jelco — ICU MEDICAL, INC. · Class II
- HSW NORM-JECT® — Henke-Sass, Wolf GmbH · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinalhealth
Sources (1)
- FDA UDI 05922de2-6937-4f74-9b54-313d7562c6c7 37 fields · synced May 30, 2026