Identity
- Trade Name
- Shape-HF FDA UDI
- Generic Name
- Pulmonary function testing kit FDA UDI
- Device Name
- Disposable Patient Interface is part of the Shape-HF testing system FDA UDI
- Model / Reference
- Disposable Patient Interface FDA UDI
- Description
- Disposable Patient Interface is part of the Shape-HF testing system FDA UDI
Identifiers
- Primary DI / UDI-DI
- B20044001 FDA UDI
- 510(k) Number
- K090722 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
No
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
Shape-HF by Shape Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pulmonary function testing kit.
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- 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
K090722 also covers:
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
- Shape Medical Systems, Inc.
Sources (1)
- FDA UDI f8b0507e-13e7-420e-9a79-6b80b90f962d 34 fields · synced May 30, 2026