Quantum SuperPAC Hybrid CPB

FDA UDIEUDAMED

by Spectrum Medical Limited

Identity

Trade Name: Quantum SuperPAC Hybrid CPB FDA UDI
Generic Name: Cardiopulmonary bypass system blood tubing set FDA UDI
Model / Reference: SPC200A-D5 FDA UDI

Identifiers

Primary DI / UDI-DI: 18051160303202 FDA UDI
GMDN Term: Cardiopulmonary bypass system blood tubing set FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Cardiopulmonary bypass system blood tubing set

Quantum SuperPAC Hybrid CPB by Spectrum Medical Limited — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system blood tubing set.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	N/A	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	N/A	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Spectrum Medical Limited

Sources (2)

FDA UDI 1762664f-3cfd-4e25-8b6d-77990489705e 32 fields · synced May 30, 2026
EUDAMED 1 fields · synced May 22, 2026