Identity
- Trade Name
- BodyFIX FDA UDI
- Generic Name
- Vacuum-mould patient positioning system FDA UDI
- Device Name
- BlueBAG™ Rectangular 480x900mm/16L vacuum cushions create a comfortable, stable and precise mold of the patient’s position. FDA UDI
- Model / Reference
- P10104-166 FDA UDI
- Description
- BlueBAG™ Rectangular 480x900mm/16L vacuum cushions create a comfortable, stable and precise mold of the patient’s position. FDA UDI
Identifiers
- Catalog Number
- P10104-166 FDA UDI
- Primary DI / UDI-DI
- 04056719000646 FDA UDI
- 510(k) Number
- K121530 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Vacuum-mould patient positioning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vacuum-mould patient positioning system
BodyFIX by 3C-Medical Intelligence GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vacuum-mould patient positioning system.
- Klarity Medical — Klarity Medical Products, LLC · Class II
- Klarity Medical — Klarity Medical Products, LLC · Class II
- Vac-Lok™ Cushion — Medtec LLC · Class II
- Vac-Lok™ Cushion — Medtec LLC · Class II
- KLARITY MEDICAL — Klarity Medical Products, LLC · Class II
- Vac-Lok™ Cushion — Medtec LLC · Class II
- VacuumCushion Pos.Strip — MACROMEDICS B.V. · Class II
- Helping Hands ™ — Medtec LLC · Class II
Cleared under the same submission
K121530 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
- 3C-Medical Intelligence GmbH
Sources (1)
- FDA UDI 80560522-d414-4df3-8517-a4cdc6ba5a78 35 fields · synced Jun 8, 2026