Shp Unit Infinity CNAP Pod
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- SHP UNT INFINITY CNAP POD EUDAMEDShp Unit Infinity CNAP Pod FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Model / Reference
- MS16905 EUDAMEDFDA UDI050685 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098050685 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04049098050685 EUDAMED
- 510(k) Number
- K102968 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electrical-only medical device connection cable, reusable
Shp Unit Infinity CNAP Pod by Draeger Medical Systems, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (2)
- FDA UDI ba156ee8-0525-4b7a-9a4a-6db85a9c7a15 34 fields · synced Jun 19, 2026
- EUDAMED b37322ff-0f48-436c-ad28-056e0691e882 61 fields · synced Jun 19, 2026