Identity
- Trade Name
- Burke FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- Foam mattress 54" width FDA UDI
- Model / Reference
- Bari-Float Mattress 54" FDA UDI
- Description
- Foam mattress 54" width FDA UDI
Identifiers
- Catalog Number
- 63410 FDA UDI
- Primary DI / UDI-DI
- B314634101 FDA UDI
- FDA Product Code
- IKY FDA UDI
- GMDN Term
- Assistive scooter, electric-motor-driven FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5150 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
No
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: Assistive scooter, electric-motor-driven
Burke by Burke, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assistive scooter, electric-motor-driven.
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- Legend XL — PRIDE MOBILITY PRODUCTS CORP. · Class II
- Go Go ES 3 Wheel — PRIDE MOBILITY PRODUCTS CORP. · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class II
- Heartway Medical Products Co., Ltd — HEARTWAY MEDICAL PRODUCTS CO., LTD. · Class II
- Vive Mobility — VIVE HEALTH LLC · Class II
- FREERIDER — Freerider Corporation · Class II
- VIVE — VIVE HEALTH 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Burke, Inc.
Sources (1)
- FDA UDI d1eb3e6c-2e39-4ca9-baaf-1cdc8bc1498f 35 fields · synced Jun 8, 2026