Identity
- Trade Name
- PFT KIT, ADInstruments Custom FDA UDI
- Generic Name
- Pulmonary function testing kit FDA UDI
- Device Name
- PFT Kit, ADInstruments Custom - disposable 35mm VBMax PFT filter, disposable Nose Clip, and reusable mouth piece FDA UDI
- Model / Reference
- PFT KIT, ADInstruments Custom - 180005 FDA UDI
- Description
- PFT Kit, ADInstruments Custom - disposable 35mm VBMax PFT filter, disposable Nose Clip, and reusable mouth piece FDA UDI
Identifiers
- Catalog Number
- 180005 FDA UDI
- Primary DI / UDI-DI
- 00817081021615 FDA UDI
- 510(k) Number
- K000654 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
Yes
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
Yes
FDA UDI
Category: Pulmonary function testing kit
PFT KIT, ADInstruments Custom by A-M Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary function testing kit.
- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- Polytech Filter — POLYTECHNIC RESOURCES, INC. · Class II
- All Flow — ALLIANCE TECH MEDICAL, INC. · Class II
- ABC Mouthpiece and Filter Kit — Aktina Corp.
- Polytech Filter — POLYTECHNIC RESOURCES, INC. · Class II
- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- Pulmoguard — SDI DIAGNOSTICS, INC. · Class II
- Polytech Filter — POLYTECHNIC RESOURCES, INC. · Class II
Cleared under the same submission
K000654 also covers:
- KIT, MIR DISPOSABLE TURBINE & VBMAX30E — A-M Systems, Inc.
- PFT KIT F, 31 MM, e-Series, / Blue Foam Nose Clips — A-M Systems, Inc.
- PFT KIT F, DISPOSABLE, VBMax34E — A-M Systems, Inc.
- PFT KIT F, DISPOSABLE, VBMax34S — A-M Systems, Inc.
- PFT KIT F, VBMax36S w/ Rubber Nose Clips — A-M Systems, Inc.
- PFT KIT J, VBMax35S, w/ Foam Nose Clip — A-M Systems, Inc.
- PFT Kit A — A-M Systems, Inc.
- PFT Kit B — A-M Systems, Inc.
- PFT Kit B, 35MM — A-M Systems, Inc.
- PFT Kit C, 30MM OD Filter — A-M Systems, Inc.
- PFT Kit C, 48 MM O.D. — A-M Systems, Inc.
- PFT Kit E, VBMax28E, w/ Foam Nose Clip — A-M Systems, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- A-M Systems, Inc.
Sources (1)
- FDA UDI 93c827fb-a4f6-43c3-ba8e-cc93b5c639b1 36 fields · synced May 30, 2026