Coil hose 10/10 (N/P) 50

FDA UDI

Class I (US FDA UDI)

by Drägerwerk AG & Co. KGaA

Identity

Trade Name: Coil hose 10/10 (N/P) 50 FDA UDI
Generic Name: Ventilator breathing circuit, reusable FDA UDI
Model / Reference: 8418458 FDA UDI

Identifiers

Primary DI / UDI-DI: 04048675028642 FDA UDI
FDA Product Code: BZO FDA UDI
GMDN Term: Ventilator breathing circuit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5975 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Ventilator breathing circuit, reusable

Coil hose 10/10 (N/P) 50 by Drägerwerk AG & Co. KGaA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Drägerwerk AG & Co. KGaA

Sources (1)

FDA UDI b1187df5-b9e3-4198-be16-6cce2eb66ecb 33 fields · synced Jun 8, 2026