← Back to catalogue
Heart® Direct Connect Continuous Nebulizer, Adult Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Heart® Direct Connect Continuous Nebulizer,Adult Kit FDA UDI
- Generic Name
- Nebulizing system delivery set, single-use FDA UDI
- Device Name
- Heart® Direct Connect Continuous Nebulizer,Adult Kit FDA UDI
- Model / Reference
- 100619 FDA UDI
- Description
- Heart® Direct Connect Continuous Nebulizer,Adult Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078000119 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nebulizing system delivery set, single-use
Heart® Direct Connect Continuous Nebulizer, Adult Kit by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nebulizing system delivery set, single-use.
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- NEBULISER ANGLED MOUTHPIECE 22M-22M — Intersurgical Incorporated · Class I
- KENOREX — KENTRON HEALTH CARE, INC. · Class II
- AMSure® Multi Adaptor — AMSINO INTERNATIONAL, INC. · Class I
- MedSource Nebulizer — MEDSOURCE INTERNATIONAL LLC · Class I
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
- Westmed, Inc.
Sources (1)
- FDA UDI 38ddd7eb-fc96-47f5-8991-cb43fd10f7fb 33 fields · synced Jun 8, 2026