Identity
- Trade Name
- CapnoSpot™ EUDAMEDPneumeric™ CapnoSpot™ Pneumothorax Decompression Indicator FDA UDI
- Generic Name
- Pleural drainage valve FDA UDI
- Device Name
- Pneumeric™ CapnoSpot™ Pneumothorax Decompression Indicator EUDAMED
- Model / Reference
- PDI-001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008954602 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600089546PDI-0013V EUDAMED
- 510(k) Number
- K223625 FDA UDI
- FDA Product Code
- GAA FDA UDI
- EMDN Code
- Z12139085 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Pleural drainage valve FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
CapnoSpot™ by Pneumeric, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08600089546PDI-0013V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pneumeric Inc.
- EUDAMED SRN
- US-MF-000041677
- Authorised Representative
- OMC NI MEDICAL LIMITED XI-AR-000019483
Sources (2)
- EUDAMED 89524a6d-3076-40fd-aee3-3c91e6a3c4b8 61 fields · synced Jul 24, 2026
- FDA UDI 14a96926-b514-45fb-81fa-6809919a9849 33 fields · synced May 30, 2026