Identity
- Trade Name
- AH! YES COCO Personal Lubricant FDA UDI
- Generic Name
- Vaginal mucosa protection dressing FDA UDI
- Device Name
- AH! YES COCO 5ml pre-filled applicators x 30 FDA UDI
- Model / Reference
- AMOB5AC30 FDA UDI
- Description
- AH! YES COCO 5ml pre-filled applicators x 30 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060104171506 FDA UDI
- 510(k) Number
- K191411 FDA UDI
- FDA Product Code
- NUC FDA UDI
- GMDN Term
- Vaginal mucosa protection dressing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5300 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal mucosa protection dressing
AH! YES COCO Personal Lubricant by Bio-Tech Lubricants, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vaginal mucosa protection dressing.
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- AH! YES OB Personal Lubricant — Bio-Tech Lubricants, Ltd. · Class II
- AH! YES WB Personal Lubricant — Bio-Tech Lubricants, Ltd. · Class II
- AH! YES VM Vaginal Moisturizer — Bio-Tech Lubricants, Ltd. · Class II
- AH! YES WB Personal Lubricant — Bio-Tech Lubricants, Ltd. · Class II
Cleared under the same submission
K191411 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Bio-Tech Lubricants, Ltd.
Sources (1)
- FDA UDI acd1919e-385c-4b62-babc-099b6347156e 36 fields · synced May 30, 2026