FDA UDI
In Commercial Distribution
🇺🇸 United States
AIV
DI: M745BC10925
·
Model: BC10925
·
AMERICAN IV PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AIV
- Primary DI
- M745BC10925
- Version / Model
- BC10925
- Catalog Number
- BC10925
- Company Name
- AMERICAN IV PRODUCTS, INC.
- Labeler DUNS
- 181184474
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 68d5bb8a-9c6c-4164-a89e-0c0967337bbe
Device Description
Patient Pendant Bolus Cable
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35932 | Patient-controlled analgesia infusion pump | A battery-powered infusion device designed to deliver intermittent bolus doses of opioid medications [e.g., Fentanyl, Demerol (meperidine), Morphine, or Hydromorphone] upon patient demand (i.e., when activated by the patient when he/she requires pain relief), or in a slow, continuous mode for regional anaesthesia. A patient-controlled analgesia (PCA) infusion pump is used to infuse drugs into an operative site, or subcutaneously for postoperative pain management. It is used for hospital/home-use and can be worn by the patient for ambulation. It will incorporate safety mechanisms to prevent the patient overdosing; some types will employ computerized ambulatory drug delivery (CADD) software. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M745BC10925 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120209 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6 | Feet | |
| Outer Diameter | 0.170 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 140 Degrees Fahrenheit