Identity
- Trade Name
- Closed Fluid System FDA UDI
- Generic Name
- Surgical fluid/gas irrigator FDA UDI
- Device Name
- Fluid Delivery Set FDA UDI
- Model / Reference
- 64-CMS04 FDA UDI
- Description
- Fluid Delivery Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848340019449 FDA UDI
- 510(k) Number
- K900187 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Surgical fluid/gas irrigator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Surgical fluid/gas irrigator
Closed Fluid System by Advance Medical Designs, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical fluid/gas irrigator.
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- IRRIGATOR/INSUFFLATOR — PENTAX of America, Inc. · Class II
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- IRRIGATOR/INSUFFLATOR — PENTAX of America, Inc. · Class II
- Surgical irrigator — LivaNova USA, Inc. · Class II
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Cleared under the same submission
K900187 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 |
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Manufacturer
- Manufacturer
- Advance Medical Designs, Inc.
Sources (1)
- FDA UDI 43c4306f-5bb0-4ec1-962c-c188dad9526a 34 fields · synced Jun 8, 2026