Identity
- Trade Name
- Prime Series FDA UDI
- Generic Name
- Hospital stretcher, powered FDA UDI
- Model / Reference
- 1125 FDA UDI
Identifiers
- Catalog Number
- 1125-000-000X FDA UDI
- Primary DI / UDI-DI
- 07613327278323 FDA UDI
- 510(k) Number
- K140095 FDA UDI
- FDA Product Code
- INK FDA UDI
- GMDN Term
- Hospital stretcher, powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3690 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
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 Unsafe FDA UDI
Category: Hospital stretcher, powered
Prime Series by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hospital stretcher, powered.
- Evacu-Trac — Garaventa (Canada) , Ltd. · Class II
- Stair-Trac — Garaventa (Canada) , Ltd. · Class II
- Electric Stretcher — Hill-Rom de México, S. de R.L. de C.V. · Class II
- Super-Trac — Garaventa (Canada) , Ltd. · Class II
- BOUNDER Plus — 21ST CENTURY SCIENTIFIC, INC. · Class II
- Stair-Porter — Garaventa (Canada) , Ltd. · Class II
- KLYO — KLYO MEDICAL SYSTEMS INC · Class II
- iBed Wireless — Stryker Corp. · Class II
Cleared under the same submission
K140095 also covers:
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
- Stryker Corp.
Sources (1)
- FDA UDI 64a85afd-c96f-4f7e-9e12-17c0c9de065d 35 fields · synced Jun 8, 2026