Identity
- Trade Name
- PFT Kit F, 35mm e-Series Kit Case FDA UDI
- Generic Name
- Pulmonary function testing kit FDA UDI
- Device Name
- Pulmonary Function Testing Kit F, 35mm e-Series Kit Case FDA UDI
- Model / Reference
- PFT Kit F, 35mm e-Series Kit - 189144 FDA UDI
- Description
- Pulmonary Function Testing Kit F, 35mm e-Series Kit Case FDA UDI
Identifiers
- Catalog Number
- 189144 FDA UDI
- Primary DI / UDI-DI
- 00817081021707 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 F, 35mm e-Series Kit Case by A-M Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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, ADInstruments Custom — 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.
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
- A-M Systems, Inc.
Sources (1)
- FDA UDI 55e514b9-ac6e-4630-a2dc-45c2ed61e12d 36 fields · synced Jun 1, 2026