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Henry Schein

FDA UDI

Class II (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Henry Schein FDA UDI
Generic Name
Nebulizing system delivery set, single-use FDA UDI
Device Name
Jet Nebulizer with Aerosol Mask Child and Oxygen Tubing FDA UDI
Model / Reference
1125619 FDA UDI
Description
Jet Nebulizer with Aerosol Mask Child and Oxygen Tubing FDA UDI

Identifiers

Catalog Number
1125619 FDA UDI
Primary DI / UDI-DI
00304040001370 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Nebulizing system delivery set, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 6 Milliliter FDA UDI

Category: Nebulizing system delivery set, single-use

Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nebulizing system delivery set, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI 650df646-ef58-442c-95b3-21b72050b97d 35 fields · synced May 30, 2026