Identity
- Trade Name
- BREEZE® BILIARY DRAINAGE CATHETER FDA UDI
- Generic Name
- Abdominal paracentesis needle, single-use FDA UDI
- Device Name
- 10F X 40CM BREEZE® BILIARY DRAIN WITHOUT LOCKING PIGTAIL SET FDA UDI
- Model / Reference
- BBNPW1040S FDA UDI
- Description
- 10F X 40CM BREEZE® BILIARY DRAIN WITHOUT LOCKING PIGTAIL SET FDA UDI
Identifiers
- Catalog Number
- BBNPW1040S FDA UDI
- Primary DI / UDI-DI
- 00884908148022 FDA UDI
- 510(k) Number
- K210419 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Abdominal paracentesis needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Abdominal paracentesis needle, single-use
Breeze® Biliary Drainage Catheter by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Abdominal paracentesis needle, single-use.
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- Skater™ Safety Centesis Catheter — Argon Medical Devices, Inc. · Class I
Cleared under the same submission
K210419 also covers:
- ACCEL® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- ACCEL® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- ACCEL® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- ACCEL® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- BREEZE® BILIARY DRAINAGE CATHETER — MEDICAL COMPONENTS INC
- BREEZE® BILIARY DRAINAGE CATHETER — MEDICAL COMPONENTS INC
- BREEZE® BILIARY DRAINAGE CATHETER — MEDICAL COMPONENTS INC
- BREEZE® BILIARY DRAINAGE CATHETER — MEDICAL COMPONENTS INC
- BREEZE® BILIARY DRAINAGE CATHETER — MEDICAL COMPONENTS INC
- BREEZE® BILIARY DRAINAGE CATHETER — MEDICAL COMPONENTS INC
- BREEZE® BILIARY DRAINAGE CATHETER — MEDICAL COMPONENTS 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 |
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Manufacturer
- Manufacturer
- Medical Components Inc
Sources (1)
- FDA UDI 95d447b3-5e99-417d-89e5-d679a980218b 36 fields · synced Jun 7, 2026