Neonatal flow sensor ISO15

FDA UDIEUDAMED

Class II (US FDA UDI)

by Drägerwerk AG & Co. KGaA

Identity

Trade Name: Neonatal flow sensor ISO15 FDA UDI
Generic Name: Breathing circuit gas-flow sensor, reusable FDA UDI
Model / Reference: 8411130 FDA UDI

Identifiers

Primary DI / UDI-DI: 04048675000099 FDA UDI
510(k) Number: K974176 FDA UDI
FDA Product Code: CBK FDA UDI
GMDN Term: Breathing circuit gas-flow sensor, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5895 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Breathing circuit gas-flow sensor, reusable

Neonatal flow sensor ISO15 by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Cleared under the same submission

K974176 also covers:

Neonatal flow sensor insert — Drägerwerk AG & Co. KGaA

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	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Drägerwerk AG & Co. KGaA

Sources (2)

FDA UDI ac0d1030-cba4-4ffe-849e-1d1639c57085 33 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 19, 2026