Identity
- Trade Name
- BD PrepMate™ Automated Accessory FDA UDI
- Generic Name
- Tissue processor IVD, automated/semi-automated FDA UDI
- Device Name
- BD PrepMate™ Automated Accessory Refurbished (100-240V) FDA UDI
- Model / Reference
- 491257 FDA UDI
- Description
- BD PrepMate™ Automated Accessory Refurbished (100-240V) FDA UDI
Identifiers
- Catalog Number
- 491257 FDA UDI
- Primary DI / UDI-DI
- 00382904912574 FDA UDI
- PMA Number
- P970018 FDA UDI
- FDA Product Code
- MKQ FDA UDI
- GMDN Term
- Tissue processor IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class III 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
Yes
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
Dimensions & Sizes
- Size
- Depth — 23 Inch FDA UDIWidth — 12.5 Inch FDA UDIHeight — 21 Inch FDA UDI
Category: Tissue processor IVD, automated/semi-automated
BD PrepMate™ Automated Accessory by Becton Dickinson And Company — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue processor IVD, automated/semi-automated.
- Leica TP1020 (Double loading) With vacuum/ with fume control — Leica Biosystems Nussloch GmbH · Class I
- Basket removal device — Leica Biosystems Nussloch GmbH · Class I
- Thermo Fisher — SHANDON DIAGNOSTICS LIMITED · Class I
- Thermo Fisher — SHANDON DIAGNOSTICS LIMITED · Class I
- Leica TP1020 (Single loading) without vacuum/ — Leica Biosystems Nussloch GmbH · Class I
- ASP6025 S 120V/50-60Hz — Leica Biosystems Nussloch GmbH · Class I
- Leica TP1020 (Double loading) Without vaccum/w — Leica Biosystems Nussloch GmbH · Class I
- Tissue-Tek Xpress® — Sakura Finetek USA, Inc · Class I
Cleared under the same submission
P970018 also covers:
- BD Density Reagent (480 ml) — BECTON DICKINSON AND COMPANY
- BD PrepMate™ Automated Accessory — BECTON DICKINSON AND COMPANY
- BD PrepMate™ Consumables Kit — BECTON DICKINSON AND COMPANY
- BD PrepStain Slide Processor — BECTON DICKINSON AND COMPANY
- BD PrepStain™ Consumables Kit — BECTON DICKINSON AND COMPANY
- BD SurePath™ Collection Vial — BECTON DICKINSON AND COMPANY
- BD SurePath™ GYN Preservative Vial Kit with Brush/Spatula — BECTON DICKINSON AND COMPANY
- BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush — BECTON DICKINSON AND COMPANY
- BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush Combi — BECTON DICKINSON AND COMPANY
- BD SurePath™ Manual Method Kit — BECTON DICKINSON AND COMPANY
- BD Syringing Pipettes — BECTON DICKINSON AND COMPANY
- BD Totalys MultiProcessor — BECTON DICKINSON AND COMPANY
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 III | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 091a6b4a-0299-4610-a867-e0e7141e8c44 38 fields · synced May 30, 2026