Identity
- Trade Name
- Kaiser Response II FDA UDI
- Generic Name
- Penile vacuum device FDA UDI
- Device Name
- External Penile Rigidity Device that contains kit bag, manual vacuum pump, constriction rings, cylinder, lubricant, cylinder inserts, loading cone. FDA UDI
- Model / Reference
- External Penile Rigidity Device FDA UDI
- Description
- External Penile Rigidity Device that contains kit bag, manual vacuum pump, constriction rings, cylinder, lubricant, cylinder inserts, loading cone. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852598007189 FDA UDI
- FDA Product Code
- LKY FDA UDI
- GMDN Term
- Penile vacuum device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5020 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Penile vacuum device
Kaiser Response II by Augusta Medical Systems, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Penile vacuum device.
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- Gesiva Medical — GESIVA MEDICAL LLC · Class II
- Dr. Joel Kaplan — DR JOEL KAPLAN INC · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Augusta Medical Systems, L.l.c.
Sources (1)
- FDA UDI 86dc0908-15ef-4d59-8888-8ab7a7ee4e2d 34 fields · synced May 31, 2026