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Spectrum With Mdl

FDA UDI

Class II (US FDA UDI)

by Baxter International Inc.

Identity

Trade Name
SPECTRUM WITH MDL FDA UDI
Generic Name
Bedside infusion pump, single-channel FDA UDI
Device Name
The Spectrum infusion pump consists of electronic circuitry and mechanisms in a plastic enclosure. The operation is software controlled, with linear peristaltic pumping design. The Spectrum is designed for the application of standard gravity infusion sets as indicated by the Spectrums labeling. FDA UDI
Model / Reference
35700BAX FDA UDI
Description
The Spectrum infusion pump consists of electronic circuitry and mechanisms in a plastic enclosure. The operation is software controlled, with linear peristaltic pumping design. The Spectrum is designed for the application of standard gravity infusion sets as indicated by the Spectrums labeling. FDA UDI

Identifiers

Catalog Number
35700BAX FDA UDI
Primary DI / UDI-DI
00085412091570 FDA UDI
FDA Product Code
FRN FDA UDI
GMDN Term
Bedside infusion pump, single-channel FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 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
MRI Safety
MR Unsafe FDA UDI

Category: Bedside infusion pump, single-channel

Spectrum With Mdl by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bedside infusion pump, single-channel.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI acce253b-2577-4b0e-9ed4-1b1045547092 36 fields · synced May 31, 2026