Identity
- Trade Name
- Infinity PiCCO SmartPod Set FDA UDI
- Generic Name
- Patient monitoring system module, cardiac output FDA UDI
- Model / Reference
- MS16734 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049098005074 FDA UDI
- 510(k) Number
- K073113 FDA UDI
- FDA Product Code
- DXG FDA UDI
- GMDN Term
- Patient monitoring system module, cardiac output FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1435 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Patient monitoring system module, cardiac output
Infinity PiCCO SmartPod Set by Draeger Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, cardiac output.
- PiCCO Module — Pulsion Medical Systems SE · Class II
- ACCUSYNC — Accusync Medical Research Corporation · Class I
- ACCUSYNC — Accusync Medical Research Corporation · Class I
- IBP_CO module(FDA/PK.) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- CO upgrd pkg/no accssry — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- ACCUSYNC — Accusync Medical Research Corporation · Class I
- ACCUSYNC — Accusync Medical Research Corporation · Class I
- C.O. accessory kit (12Pin) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
Cleared under the same submission
K073113 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
- Draeger Medical Systems, Inc.
Sources (1)
- FDA UDI 9f3b9645-cebf-4421-af89-1825c9ec7907 34 fields · synced Jun 9, 2026