Identity
- Trade Name
- Assy, 25' Pulmo Chest Bellows FDA UDI
- Generic Name
- Breath-hold system patient belt, pneumatic FDA UDI
- Device Name
- Assy, 25' Pulmo Chest Bellows FDA UDI
- Model / Reference
- A01A103LONG FDA UDI
- Description
- Assy, 25' Pulmo Chest Bellows FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851607003112 FDA UDI
- FDA Product Code
- HCC FDA UDI
- GMDN Term
- Breath-hold system patient belt, pneumatic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Breath-hold system patient belt, pneumatic
Assy, 25' Pulmo Chest Bellows by Medspira Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breath-hold system patient belt, pneumatic.
- Assy, Philips 23' Pulmo Chest Bellows, Tubing ES — MEDSPIRA LLC · Class II
- Assy, Pulmo Chest Bellows, Tubing — MEDSPIRA LLC · Class II
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
- Medspira Llc
Sources (1)
- FDA UDI 107e8ec8-6d20-4815-8acb-ebc15b2148a5 34 fields · synced Jun 8, 2026