HOPE Nebulizer - Pediatric Kit

FDA UDI

Class II (US FDA UDI)

by B & B Medical Technologies, Inc.

Identity

Trade Name: HOPE Nebulizer - Pediatric Kit FDA UDI
Generic Name: Nebulizing system delivery set, single-use FDA UDI
Device Name: Pediatric Nebulizer Kit with 6' Aerosol Tubing, Contains 10 Units FDA UDI
Model / Reference: 11330 FDA UDI
Description: Pediatric Nebulizer Kit with 6' Aerosol Tubing, Contains 10 Units FDA UDI

Identifiers

Catalog Number: 11330 FDA UDI
Primary DI / UDI-DI: 00850008733017 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Nebulizing system delivery set, single-use

HOPE Nebulizer - Pediatric Kit by B & B Medical Technologies, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: B & B Medical Technologies, Inc.

Sources (1)

FDA UDI d710b936-93a8-4765-a7bd-52c373388a00 34 fields · synced Jun 8, 2026