FDA UDI
In Commercial Distribution
🇺🇸 United States
SINGLE LEAD HIGH VOLUME PUMP CHAMBER SET
DI: 00810080610552
·
Model: 17789HP3MLL-10PK
·
MPS Pharma & Medical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SINGLE LEAD HIGH VOLUME PUMP CHAMBER SET
- Primary DI
- 00810080610552
- Version / Model
- 17789HP3MLL-10PK
- Company Name
- MPS Pharma & Medical, Inc.
- Labeler DUNS
- 117970217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-24
- Public Version
- 1
- Public Version Date
- 2022-09-01
- Public Version Status
- New
- Public Device Record Key
- 147d46d9-ec15-4909-b074-b706d73e81a1
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEP | System/Device, Pharmacy Compounding | General Hospital | 880.5440 | 2 |
| JTB | Device, Media Dispensing/Stacking | Microbiology | 866.2440 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41646 | Compounding transfer set | A collection of sterile items typically used in the clinical pharmacy or a manufacturing plant to provide a sterile fluid path for the compounding (mixing) of different multi-ingredient solutions from multiple source containers into a final suitable container. It is typically available in a variety of configurations (e.g., as a 6-lead or a 9-lead set) and includes, e.g., tubes, connectors, spikes. This device may also be used for intravenous (IV) solution compounding. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810080610559 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00810080610552 | GS1 |