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Suretrans

FDA UDI

Class II (US FDA UDI)

by Davol Inc.

Identity

Trade Name
SURETRANS FDA UDI
Generic Name
Whole-blood-recovery autotransfusion system, manual FDA UDI
Device Name
SureTrans PVC Round Drain FDA UDI
Model / Reference
8597000 FDA UDI
Description
SureTrans PVC Round Drain FDA UDI

Identifiers

Catalog Number
8597000 FDA UDI
Primary DI / UDI-DI
00801741065453 FDA UDI
FDA Product Code
CAC FDA UDI
GMDN Term
Whole-blood-recovery autotransfusion system, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5830 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

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

Dimensions & Sizes

Size
Outer Diameter — 4.7 Millimeter FDA UDI

Category: Whole-blood-recovery autotransfusion system, manual

Suretrans by Davol Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Whole-blood-recovery autotransfusion system, manual.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Davol Inc.

Sources (1)

  • FDA UDI ef831cef-3941-413f-8c89-06f3d22df860 37 fields · synced Jun 6, 2026