FDA UDI
In Commercial Distribution
🇺🇸 United States
PMI
DI: 00812608022250
·
Model: PMIFR300
·
PROGRESSIVE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PMI
- Primary DI
- 00812608022250
- Version / Model
- PMIFR300
- Company Name
- PROGRESSIVE MEDICAL, INC.
- Labeler DUNS
- 192135242
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-29
- Public Version
- 2
- Public Version Date
- 2021-03-05
- Public Version Status
- Update
- Public Device Record Key
- b35d8282-bb4d-4a8c-b2de-82820757dad4
Device Description
PMI IV admin set with flow regulator, 100" length, 20 drop, 15 micron filter in drip chamber, rotating male luer lock, vented cap with 0.2 micron in-line filter
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
- No
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12170 | Intravenous administration tubing extension set | A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00812608022267 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 00812608022250 | GS1 |