Identity
- Trade Name
- CO-SET+ FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- CO-SET(R) AND SYRINGE F/USE W/ 93-500,-510,-600,-610 5EA/CA FDA UDI
- Model / Reference
- 93650 FDA UDI
- Description
- CO-SET(R) AND SYRINGE F/USE W/ 93-500,-510,-600,-610 5EA/CA FDA UDI
Identifiers
- Catalog Number
- 93650 FDA UDI
- Primary DI / UDI-DI
- 07460691950016 FDA UDI
- 510(k) Number
- K811399 FDA UDI
- FDA Product Code
- KRB FDA UDI
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1915 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 — 10 Milliliter FDA UDI
Category: General-purpose syringe, single-use
Co-Set+ by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose syringe, single-use.
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- SOFT-JECT® — Henke-Sass, Wolf GmbH · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- SURGYCO — Surgyco LLC · Class I
- NAMIC — MEDLINE INDUSTRIES, INC. · Class II
- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
- SURGYCO — Surgyco LLC · Class I
Cleared under the same submission
K811399 also covers:
- CO-SET INJECTATE ICE BUCKET — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
- CO-SET+ — Edwards Lifesciences LLC
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
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI 0d81b388-4ddb-4138-ba40-70185a6d6e52 38 fields · synced Jun 8, 2026