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First Step Bedside Kit - Stand-Up Pouch, Gemini Cleaning Pad
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- First Step Bedside Kit - Stand-Up Pouch, Gemini Cleaning Pad FDA UDI
- Generic Name
- Medical device cleaning sponge/set FDA UDI
- Device Name
- First Step Bedside Kit - Stand-Up Pouch, Gemini Cleaning Pad - 1 Pouch FDA UDI
- Model / Reference
- EP-4G FDA UDI
- Description
- First Step Bedside Kit - Stand-Up Pouch, Gemini Cleaning Pad - 1 Pouch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843356100280 FDA UDI
- FDA Product Code
- MNL FDA UDI
- GMDN Term
- Medical device cleaning sponge/set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device cleaning sponge/set
First Step Bedside Kit - Stand-Up Pouch, Gemini Cleaning Pad by Cygnus Medical L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- SUMMIT MEDICAL — Summit Medical, LLC · Class II
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
- Cygnus Medical L.l.c.
Sources (1)
- FDA UDI 59e13a05-488d-49ad-831d-215d19079e9a 33 fields · synced May 30, 2026