DART-Reach

FDA UDI

Class II (US FDA UDI)

by Engineered Medical Systems, LLC

Identity

Trade Name: DART-Reach FDA UDI
Generic Name: Atomizer, non-ventilatory FDA UDI
Model / Reference: 301-REACH720 FDA UDI

Identifiers

Primary DI / UDI-DI: 00841470103811 FDA UDI
510(k) Number: K070596 FDA UDI
FDA Product Code: CCT FDA UDI
GMDN Term: Atomizer, non-ventilatory FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5170 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

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

Dimensions & Sizes

Size: Length — 117 Millimeter FDA UDI

Category: Atomizer, non-ventilatory

DART-Reach by Engineered Medical Systems, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Atomizer, non-ventilatory.

LMA ATOMIZATION — TELEFLEX INCORPORATED · Class I
Ventlab — Ventlab Corp. · Class II
LMA ATOMIZATION — TELEFLEX INCORPORATED · Class I
Ventlab — Ventlab Corp. · Class II
MINI JET NEBULIZER SET 6CC/OD:18mm(W/O CORRUGATE TUBING) — BESMED HEALTH BUSINESS CORP. · Class II
Ventlab — Ventlab Corp. · Class II
BR Surgical, LLC — BR SURGICAL LLC · Class I
Ventlab — Ventlab Corp. · Class II

Cleared under the same submission

K070596 also covers:

DART-Reach — Engineered Medical Systems, LLC
DART-Reach — Engineered Medical Systems, LLC
DART-Reach — Pulmodyne Inc.
DART-Reach — Pulmodyne Inc.
DART-Reach — Pulmodyne Inc.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Engineered Medical Systems, LLC

Sources (1)

FDA UDI e5d0f735-b47c-489b-ace2-c1002b76067b 34 fields · synced May 31, 2026