Identity
- Trade Name
- ULTRADRAPE 2 FDA UDI
- Generic Name
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
- Device Name
- Ultradrape II UGPIV EUDAMEDUltrasound Guided Peripheral Intravenous Barrier and Securement Device 4.68 in x 2.63 in FDA UDI
- Model / Reference
- 34-10 EUDAMEDUltrasound Guided Peripheral Intravenous Barrier and Securement Device FDA UDI
- Description
- Ultrasound Guided Peripheral Intravenous Barrier and Securement Device 4.68 in x 2.63 in FDA UDI
Identifiers
- Catalog Number
- 34-10 FDA UDI
- Primary DI / UDI-DI
- 10855683006965 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10855683006965 EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- M04010299 FIXING DRESSINGS - OTHER EUDAMED
- GMDN Term
- Synthetic polymer semi-permeable film dressing, adhesive FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Ultradrape II UGPIV by Parker Laboratories, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10855683006965 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parker Laboratories, Inc.
- EUDAMED SRN
- US-MF-000013857
- Authorised Representative
- Parker Laboratories, BV NL-AR-000012618
Sources (2)
- EUDAMED ca7fca47-ca1d-48d9-ae5c-1c25457969c7 61 fields · synced Jul 11, 2026
- FDA UDI f7cc50a9-6e8b-4d34-82f4-3667660033aa 36 fields · synced May 30, 2026