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Kit, Sample, Agents, 3160

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 94018

by Invivo, a division of Philips Medical Systems

Identity

Trade Name
Kit, Sample, Agents, 3160 EUDAMED
MR Patient Care Kit, Sample, Agents, 3160 FDA UDI
Generic Name
Exhaled-gas sample collector, non-electronic FDA UDI
Device Name
Single Use Gas Sampling Line EUDAMED
KIT,SAMPLE,AGENTS,3160 FDA UDI
Model / Reference
94018 EUDAMED
Kit, Sample, Agents, 3160 FDA UDI
Description
KIT,SAMPLE,AGENTS,3160 FDA UDI

Identifiers

Catalog Number
94018 FDA UDI
Primary DI / UDI-DI
00884838109919 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM860TL EUDAMED
FDA Product Code
MWI FDA UDI
EMDN Code
Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
GMDN Term
Exhaled-gas sample collector, non-electronic FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Kit, Sample, Agents, 3160 by Invivo, a division of Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Invivo, a division of Philips Medical Systems
EUDAMED SRN
US-MF-000002177
Authorised Representative
Philips Medizin Systeme Böblingen GmbH DE-AR-000006030

Sources (2)

  • EUDAMED 32857d47-33dc-47c4-9ee3-79d1e519a815 61 fields · synced Oct 6, 2026
  • FDA UDI 95d52692-486c-42ab-8061-eb3eb2fbc9fd 36 fields · synced May 30, 2026