Identity
- Trade Name
- All Flow FDA UDI
- Generic Name
- Pulmonary function testing kit FDA UDI
- Model / Reference
- 7775100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00384620000115 FDA UDI
- 510(k) Number
- K043148 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
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
No
FDA UDI
Category: Pulmonary function testing kit
All Flow by Alliance Tech Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K043148 also covers:
- All Flow — ALLIANCE TECH MEDICAL, INC.
- All Flow — ALLIANCE TECH MEDICAL, INC.
- All Flow — ALLIANCE TECH MEDICAL, INC.
- All Flow — ALLIANCE TECH MEDICAL, INC.
- All Flow — ALLIANCE TECH MEDICAL, INC.
- All Flow — ALLIANCE TECH MEDICAL, INC.
- All Flow — ALLIANCE TECH MEDICAL, INC.
- All Flow — ALLIANCE TECH MEDICAL, INC.
- All Flow — ALLIANCE TECH MEDICAL, INC.
- All Flow — ALLIANCE TECH MEDICAL, INC.
- All Flow — ALLIANCE TECH MEDICAL, INC.
- All Flow — ALLIANCE TECH MEDICAL, 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
- Alliance Tech Medical, Inc.
Sources (1)
- FDA UDI 51ebac9a-24eb-437a-a739-ab13b78acabe 33 fields · synced May 30, 2026