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CS300 Accessory Kit, Swedish, 220 V

FDA UDI

Class II (US FDA UDI)

by Datascope Corp.

Identity

Trade Name
CS300 Accessory Kit, Swedish, 220 V FDA UDI
Generic Name
Intra-aortic balloon pump FDA UDI
Device Name
CS300 Accessory Kit, Swedish, 220 V FDA UDI
Model / Reference
0020-00-0482-09 FDA UDI
Description
CS300 Accessory Kit, Swedish, 220 V FDA UDI

Identifiers

Catalog Number
0020-00-0482-09 FDA UDI
Primary DI / UDI-DI
10607567112527 FDA UDI
FDA Product Code
DSP FDA UDI
GMDN Term
Intra-aortic balloon pump FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3535 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

Yes

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

Category: Intra-aortic balloon pump

CS300 Accessory Kit, Swedish, 220 V by Datascope Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intra-aortic balloon pump.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Datascope Corp.

Sources (1)

  • FDA UDI eea2b387-4fb7-41bd-8c1e-0491f37e79da 35 fields · synced May 30, 2026