Identity
- Trade Name
- Pulmoguard FDA UDI
- Generic Name
- Pulmonary function testing kit FDA UDI
- Device Name
- Bacterial Filter FDA UDI
- Model / Reference
- IQ, Kushion Klip FDA UDI
- Description
- Bacterial Filter FDA UDI
Identifiers
- Catalog Number
- F0611-025 FDA UDI
- Primary DI / UDI-DI
- B279F0611025 FDA UDI
- 510(k) Number
- K934509 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Pulmonary function testing kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Category: Pulmonary function testing kit
Pulmoguard by Sdi Diagnostics, 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
- 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.
- PFT Kit E, VBMax36E — A-M Systems, Inc. · Class II
Cleared under the same submission
K934509 also covers:
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
- Pulmoguard — SDI DIAGNOSTICS, INC.
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 |
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Manufacturer
- Manufacturer
- Sdi Diagnostics, Inc.
Sources (1)
- FDA UDI d4017b3e-338b-47f6-9c23-513eb4f8b4c4 35 fields · synced May 30, 2026