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Smt

FDA UDI

Class I (US FDA UDI)

by Ceodeux S.a.

Identity

Trade Name
SMT FDA UDI
Generic Name
Nitric oxide refillable cylinder FDA UDI
Model / Reference
301969000378 FDA UDI

Identifiers

Catalog Number
SCI-280 FDA UDI
Primary DI / UDI-DI
05430003710005 FDA UDI
FDA Product Code
ECX FDA UDI
GMDN Term
Nitric oxide refillable cylinder FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.2700 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nitric oxide refillable cylinder

Smt by Ceodeux S.a. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nitric oxide refillable cylinder.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ceodeux S.a.

Sources (1)

  • FDA UDI 507a35d0-d856-4140-8fc1-fcf5922f98ad 33 fields · synced Jun 8, 2026