Identity
- Trade Name
- 8311 PNT FDA UDI
- Generic Name
- Pneumotachograph FDA UDI
- Device Name
- SMC 462535: CUSTOM PNT 8311B FDA UDI
- Model / Reference
- 8311 FDA UDI
- Description
- SMC 462535: CUSTOM PNT 8311B FDA UDI
Identifiers
- Catalog Number
- 112762 FDA UDI
- Primary DI / UDI-DI
- 00817136026220 FDA UDI
- FDA Product Code
- JAX FDA UDI
- GMDN Term
- Pneumotachograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2550 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
8311 Pnt by Hans Rudolph, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Hans Rudolph, Inc.
Sources (1)
- FDA UDI 75aa4e3f-8c88-4787-b474-2032aa997b52 35 fields · synced May 29, 2026