AllPoints Port Access System MiniLoc
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MINILOC EUDAMEDAllPoints Port Access System MiniLoc FDA UDIPort Access Needle FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDIVascular port administration set FDA UDI
- Device Name
- MiniLoc™ Safety Infusion Set EUDAMEDAllPoints Port Access System MiniLoc 20G x 1 inch with Y-Site FDA UDIMiniLoc 20G x 1 inch FDA UDI
- Model / Reference
- 0632010 EUDAMEDFDA UDIAN682010 FDA UDI
- Description
- AllPoints Port Access System MiniLoc 20G x 1 inch with Y-Site FDA UDIMiniLoc 20G x 1 inch FDA UDI
Identifiers
- Catalog Number
- AN682010 FDA UDI0632010 FDA UDI
- Primary DI / UDI-DI
- 00801741047541 EUDAMEDFDA UDI00801741215414 FDA UDI
- Basic UDI-DI
- 0801741NPERWKIL4F EUDAMED
- FDA Product Code
- FPA FDA UDI
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDIVascular port administration set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
Yes
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Needle Gauge — 20 Gauge FDA UDILength — 1.0 Inch FDA UDILength — 1 Inch FDA UDI
Category: Peripheral angioplasty balloon catheter, basic
AllPoints Port Access System MiniLoc by Bard Access Systems, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bard Access Systems, Inc.
Sources (3)
- FDA UDI 1136abc9-ac47-44cc-961a-48b8c0c7bbef 37 fields · synced Jul 8, 2026
- FDA UDI 64ed1df0-16ad-4cb8-8737-1b1b42474adb 36 fields · synced May 25, 2026
- EUDAMED 572327d3-e1c8-49ae-862f-86f654c1ab0c 61 fields · synced Jul 8, 2026