Identity
- Trade Name
- Philips BlueBand FDA UDI
- Generic Name
- Vulnerable patient home alert system FDA UDI
- Device Name
- BlueBand Wearable Device FDA UDI
- Model / Reference
- 300004069001 FDA UDI
- Description
- BlueBand Wearable Device FDA UDI
Identifiers
- Catalog Number
- BBM0110 FDA UDI
- Primary DI / UDI-DI
- 00884838097551 FDA UDI
- FDA Product Code
- ILQ FDA UDI
- GMDN Term
- Vulnerable patient home alert system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3710 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
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vulnerable patient home alert system
Philips BlueBand by Lifeline Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vulnerable patient home alert system.
- IQ SENSOR ALARM 10/CA — AliMed, LLC · Class I
- IQ SENSOR CONTACT ALARM W/FLOOR MAT SYSTEM — AliMed, LLC · Class I
- SEAT BELT REPLACEMENT FOR 77667 SEAT BELT ALARM — AliMed, LLC · Class I
- ALARM DOOR BANNER ALIMED — AliMed, LLC · Class I
- IQ SENSOR ALARM W/UNIVERSAL ALARM STRAP SYSTEM — AliMed, LLC · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- Fall monitor — Securitas Healthcare LLC · Class I
- SEATBELT EZ RELEASE EARLY WARNING — AliMed, LLC · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lifeline Systems, Inc.
Sources (1)
- FDA UDI a5c94b6d-be1e-4636-86ed-8d9f1ed13f33 34 fields · synced Jun 6, 2026