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Anesth Set Flex 160 (BagCone OD22)

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref MP16029Model 2080456K19T010

by Drägerwerk AG & Co. KGaA

Identity

Trade Name
Anaesth Set Flex 160 (BK OD22) EUDAMED
Anesth Set Flex 160 (BagCone OD22) FDA UDI
Generic Name
Anaesthesia breathing circuit, single-use FDA UDI
Model / Reference
MP16029 EUDAMEDFDA UDI
2080456K19T010 EUDAMED

Identifiers

Primary DI / UDI-DI
04048675715252 EUDAMEDFDA UDI
Basic UDI-DI
0404867512080456K19T010TS EUDAMED
FDA Product Code
CAI FDA UDI
BZO FDA UDI
EMDN Code
R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
GMDN Term
Anaesthesia breathing circuit, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
868.5240 FDA UDI
868.5975 FDA UDI
Market of Registration
Germany 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Anesth Set Flex 160 (BagCone OD22) by Drägerwerk AG & Co. KGaA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Drägerwerk AG & Co. KGaA

Sources (2)

  • FDA UDI bf1466bf-1444-408a-a579-4aef715cd8ed 33 fields · synced Oct 6, 2026
  • EUDAMED ab3f6ff2-d12e-440a-b9ef-3930b8159b34 61 fields · synced Jul 24, 2026