Identity
- Trade Name
- I-MED Protective Isolation Gown FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- The I-MED Protective Isolation Gowns provide anti-bacterial protection with a comfortable fit. The I-MED Protective Isolation Gowns are manufactured from a premium impervious SMS material base fabric and are available in white and sizes S to 2XL. 100% waterproof efficiency and high-repellency medical-grade protection Ties at back of neck and waist, with elastic wrist or knitted cuff. FDA UDI
- Model / Reference
- 5500 FDA UDI
- Description
- The I-MED Protective Isolation Gowns provide anti-bacterial protection with a comfortable fit. The I-MED Protective Isolation Gowns are manufactured from a premium impervious SMS material base fabric and are available in white and sizes S to 2XL. 100% waterproof efficiency and high-repellency medical-grade protection Ties at back of neck and waist, with elastic wrist or knitted cuff. FDA UDI
Identifiers
- Catalog Number
- 5500 FDA UDI
- Primary DI / UDI-DI
- 00622554055000 FDA UDI
- FDA Product Code
- FME FDA UDI
- GMDN Term
- Isolation gown, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6265 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Isolation gown, single-use
I-MED Protective Isolation Gown by I-Med Pharma Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- I-Med Pharma Inc
Sources (1)
- FDA UDI f00ccebb-e612-46aa-a48d-3f8afd376b7b 35 fields · synced May 30, 2026