PremierPro 8811
PremierPro 8811 is a Class I device made by Prestige Ameritech, listed in FDA GUDID since 29 Aug 2020 (UDI-DI 00818566019622), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00818566019622 | Date29 Aug 2020 | StatusListed |
Official records
- AccessGUDID record 00818566019622
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- PremierPro
- Generic name
- Intravenous pressure infusor, manual, reusable
- Model / Ref / Catalog
- 8811
- Primary DI / UDI-DI
- 00818566019622
- FDA product code
- KZD
- GMDN term
- Intravenous pressure infusor, manual, reusable
- Device class
- Class I
- Regulation number
- 880.5420
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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