Identity
- Trade Name
- Assure® Slide Pill Swallowing Aid zero FDA UDI
- Generic Name
- Pill swallowing lubricant FDA UDI
- Device Name
- Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100032 is used as the assigned UDI for the Class I device.) FDA UDI
- Model / Reference
- 1000003 FDA UDI
- Description
- Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100032 is used as the assigned UDI for the Class I device.) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00015482100032 FDA UDI
- FDA Product Code
- NXB FDA UDI
- GMDN Term
- Pill swallowing lubricant FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Assure® Slide Pill Swallowing Aid zero by Arkray Usa, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Arkray Usa, Inc.
Sources (1)
- FDA UDI f71c4505-6ea6-495c-8b26-4af4f2100ab6 36 fields · synced May 30, 2026