Identity
- Trade Name
- AQUIST WASHABLE ISOLATION GOWN FDA UDI
- Generic Name
- Isolation gown, reusable FDA UDI
- Model / Reference
- 6070553482 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D89260705534821 FDA UDI
- FDA Product Code
- OEA FDA UDI
- GMDN Term
- Isolation gown, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Isolation gown, reusable
Aquist Washable Isolation Gown by Maxill, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Isolation gown, reusable.
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- Generic Polyester Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- ComPel Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- HENRY SCHEIN — HENRY SCHEIN, INC. · Class II
- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC · Class II
- Precaution/Isolation Gown — STANDARD TEXTILE CO., INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maxill, Inc.
Sources (1)
- FDA UDI e6d69722-9e2f-4203-91d0-2c8fa2c98e45 32 fields · synced Jun 1, 2026