BodyMed

FDA UDI

Class II (US FDA UDI)

by Boxout, Llc

Identity

Trade Name: BodyMed FDA UDI
Generic Name: Therapeutic agent nebulizer, benchtop FDA UDI
Device Name: BODYMED COMPRESSOR NEBULIZER SYSTEM, COMPACT DESIGN, WITH DISPOSIBLE AND REUSABLE NEBULIZER KIT INCLUDED FDA UDI
Model / Reference: BDMNEBCOMREU FDA UDI
Description: BODYMED COMPRESSOR NEBULIZER SYSTEM, COMPACT DESIGN, WITH DISPOSIBLE AND REUSABLE NEBULIZER KIT INCLUDED FDA UDI

Identifiers

Primary DI / UDI-DI: 00815991025167 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Therapeutic agent nebulizer, benchtop 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Therapeutic agent nebulizer, benchtop Nebulizing system delivery set, reusable

BodyMed by Boxout, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nebulizing system delivery set, reusable.

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Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II
Nebulizer Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
Schuco — Allied Medical LLC · Class II
Yirdoc — Qingdao Future Medical Technology Co., Ltd. · Class II
VixOne™ Reusable Nebulizer — WESTMED, INC. · Class II
Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II

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: Boxout, Llc

Sources (1)

FDA UDI 58730e0a-9a18-4637-9138-5e2ba62521f7 34 fields · synced May 30, 2026