Identity
- Trade Name
- prolaio Convenience Kit FDA UDI
- Generic Name
- Electrocardiography monitoring system receiver FDA UDI
- Device Name
- prolaio Convenience Kit - Model B FDA UDI
- Model / Reference
- B FDA UDI
- Description
- prolaio Convenience Kit - Model B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850071330090 FDA UDI
- GMDN Term
- Electrocardiography monitoring system receiver FDA UDI
Classification
- 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiography monitoring system receiver
prolaio Convenience Kit by Prolaio, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Prolaio, Inc.
Sources (1)
- FDA UDI 72b91b41-68a4-47ea-8244-9bc11b294482 33 fields · synced May 30, 2026