Identity
- Trade Name
- Monoject FDA UDI
- Generic Name
- Irrigation syringe FDA UDI
- Device Name
- 300 USP Units/3 mL (100 USP Units/mL) Heparin Lock,Flush Syringe, 3 mL Fill FDA UDI
- Model / Reference
- 8881590123 FDA UDI
- Description
- 300 USP Units/3 mL (100 USP Units/mL) Heparin Lock,Flush Syringe, 3 mL Fill FDA UDI
Identifiers
- Catalog Number
- 8881590123 FDA UDI
- Primary DI / UDI-DI
- 10884521005822 FDA UDI
- 510(k) Number
- K032438 FDA UDI
- FDA Product Code
- NGT FDA UDI
- GMDN Term
- Irrigation syringe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 3 Milliliter FDA UDI
Category: Irrigation syringe
Monoject by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Irrigation syringe.
- Centurion — Centurion Medical Products · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- IRRIJET® Single-Use — CooperSurgical, Inc. · Class I
- Dover — Cardinal Health 200, LLC · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- PROBEVAC — PLASDENT CORP. · Class I
- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
Cleared under the same submission
K032438 also covers:
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 edd96f44-94e7-4332-aedb-a77935cab31b 38 fields · synced Jun 8, 2026