FDA UDI
In Commercial Distribution
🇺🇸 United States
MediChoice
DI: 10885632134449
·
Model: 230500
·
OWENS & MINOR DISTRIBUTION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- MediChoice
- Primary DI
- 10885632134449
- Version / Model
- 230500
- Company Name
- OWENS & MINOR DISTRIBUTION, INC.
- Labeler DUNS
- 007941230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-04
- Public Version
- 1
- Public Version Date
- 2020-12-14
- Public Version Status
- New
- Public Device Record Key
- 9681ba4d-f8db-4ffb-a46a-481d90055e37
Device Description
Bag Infuser Pressure 500 Cubic Centimeter Nylon Disposable Not Made With Natural Rubber Latex Non-Sterile MediChoice
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KZD | INFUSOR, PRESSURE, FOR I.V. BAGS | General Hospital | 880.5420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65172 | Intravenous pressure infusor, manual, single-use | A manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30885632130049 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 10885632134449 | GS1 | ||||
| Package | 50885632134447 | GS1 | 5 | In Commercial Distribution |