Identity
- Trade Name
- BREEZE® SECUREMENT FDA UDI
- Generic Name
- Wearable percutaneous catheter/tube holder FDA UDI
- Device Name
- BREEZE® DRAIN LOCK 12F -18F FDA UDI
- Model / Reference
- BL1218 FDA UDI
- Description
- BREEZE® DRAIN LOCK 12F -18F FDA UDI
Identifiers
- Catalog Number
- BL1218 FDA UDI
- Primary DI / UDI-DI
- 00884908140804 FDA UDI
- FDA Product Code
- KMK FDA UDI
- GMDN Term
- Wearable percutaneous catheter/tube holder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
Category: Wearable percutaneous catheter/tube holder
Breeze® Securement by Medical Components Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wearable percutaneous catheter/tube holder.
- SecurePortIV — Adhezion Biomedical, LLC · Class II
- Grip-Lok — TIDI PRODUCTS, LLC · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- CathGrip — ARGENTUM MEDICAL, LLC · Class I
- Centurion — Centurion Medical Products · Class I
- CathGrip — ARGENTUM MEDICAL, LLC · Class I
- Cook — COOK INCORPORATED · Class I
- Grip-Lok — TIDI PRODUCTS, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Medical Components Inc
Sources (1)
- FDA UDI 4b9fdcac-7647-4903-b84a-fece92aef5d8 35 fields · synced May 30, 2026