Identity
- Trade Name
- AIV FDA UDI
- Generic Name
- Patient-controlled analgesia infusion pump FDA UDI
- Device Name
- Patient Pendant Bolus Cable FDA UDI
- Model / Reference
- BC10969 FDA UDI
- Description
- Patient Pendant Bolus Cable FDA UDI
Identifiers
- Catalog Number
- BC10969 FDA UDI
- Primary DI / UDI-DI
- M745BC10969 FDA UDI
- 510(k) Number
- K120209 FDA UDI
- FDA Product Code
- MRZ FDA UDI
- GMDN Term
- Patient-controlled analgesia infusion pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 6 Feet FDA UDIOuter Diameter — 0.170 Inch FDA UDI
Aiv by American I.v. Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K120209 also covers:
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
- American I.v. Products, Inc.
Sources (1)
- FDA UDI eb8c2d4f-3cfa-4692-86c7-91e1fb87a330 38 fields · synced May 31, 2026