Identity
- Trade Name
- Disposable Patient Interface with filter FDA UDI
- Generic Name
- Pulmonary function testing kit FDA UDI
- Device Name
- Disposable patient interface with filter 0004-4012 FDA UDI
- Model / Reference
- 0004-4012 FDA UDI
- Description
- Disposable patient interface with filter 0004-4012 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B20044012 FDA UDI
- 510(k) Number
- K150888 FDA UDI
- FDA Product Code
- BTY FDA UDI
- GMDN Term
- Pulmonary function testing kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1890 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pulmonary function testing kit
Disposable Patient Interface with filter by Shape Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary function testing kit.
- PFT Kit E, VBMax30E — A-M Systems, Inc. · Class II
- PFT KIT F, DISPOSABLE, VBMax34S — A-M Systems, Inc. · Class II
- PFT Kit F, VBMax 36E — A-M Systems, Inc. · Class II
- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- Polytech Filter — POLYTECHNIC RESOURCES, INC. · Class II
- KIT, MIR DISPOSABLE TURBINE & VBMAX30E — A-M Systems, Inc. · Class II
- All Flow — ALLIANCE TECH MEDICAL, INC. · Class II
- ABC Mouthpiece and Filter Kit — Aktina Corp.
Cleared under the same submission
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
- Shape Medical Systems, Inc.
Sources (1)
- FDA UDI cadd86d7-3ffe-4cb8-a14b-84a86a723567 34 fields · synced Jun 8, 2026