Identity
- Trade Name
- Mannequin™ Endoventricular Shaper FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Device Name
- Mannequin™ Endoventricular Shaper, 90cc FDA UDI
- Model / Reference
- VRD-0090S FDA UDI
- Description
- Mannequin™ Endoventricular Shaper, 90cc FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00899054002098 FDA UDI
- 510(k) Number
- K020233 FDA UDI
- FDA Product Code
- DXZ FDA UDI
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Catheter/overtube balloon inflator, single-use
Mannequin™ Endoventricular Shaper by Kdl Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K020233 also covers:
- Mannequin™ Endoventricular Shaper — KDL MEDICAL, INC.
- Mannequin™ Endoventricular Shaper — KDL MEDICAL, INC.
- Mannequin™ Endoventricular Shaper — KDL MEDICAL, INC.
- Mannequin™ Endoventricular Shaper — KDL MEDICAL, INC.
- Mannequin™ Endoventricular Shaper — KDL MEDICAL, INC.
- Mannequin™ Endoventricular Shaper — KDL MEDICAL, INC.
- Mannequin™ Endoventricular Shaper — KDL MEDICAL, INC.
- Mannequin™ Endoventricular Shaper — KDL MEDICAL, INC.
- SVR System without Patch — KDL MEDICAL, INC.
- SVR System without Patch — KDL MEDICAL, INC.
- SVR System without Patch — KDL MEDICAL, INC.
- SVR System without Patch — KDL MEDICAL, INC.
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
- Kdl Medical, Inc.
Sources (1)
- FDA UDI 1a01871f-6be2-4684-9ae5-62432ec8626b 34 fields · synced May 30, 2026