FDA Device Establishments · JSON-LD · Markdown
FEI 3013269506 · Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3013269506 |
|---|---|
| Owner / Operator | Two One Two New York, Inc. (#10077084) |
| Address | 60 Heartland Blvd, Edgewood, NY, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | OEA |
| Regulation § (21 CFR) | 878.4040 |
| Proprietary names | LEVEL 2 DISPOSABLE ISOLATION GOWN MODEL 27000XL; LEVEL 2 DISPOSABLE ISOLATION GOWN MODEL 27000L; IIJA COMPLIANT DISPOSABLE ISOLATION GOWN LEVEL 2 ANSI/AAMI; REUSABLE ISOLATION GOWN LEVEL 1 ANSI/AAMI; DISPOSABLE AAMI ISOLATION GOWN LEVEL 3; DISPOSABLE SURGICAL GOWN AAMI LEVEL 2 NON-STERILE; DISPOSABLE ISOLATION GOWN ANSI/AAMI LEVEL 2; DISPOSABLE ISOLATION GOWN LEVEL 1 ANSI/AAMI; DISPOSABLE ISOLATION GOWN LEVEL 3 ANSI/AAMI |
Source: openFDA. Public-domain (CC0).