Identity
- Trade Name
- Ultradrape FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- Ultradrape UGPIV EUDAMEDUltrasound Guided Peripheral Intravenous Barrier and Securement Device 3.25''x5.8'' FDA UDI
- Model / Reference
- 34-15 EUDAMEDFDA UDI
- Description
- Ultrasound Guided Peripheral Intravenous Barrier and Securement Device 3.25''x5.8'' FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10855683006545 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10855683006545 EUDAMED
- 510(k) Number
- K780973 FDA UDI
- FDA Product Code
- GYB FDA UDI
- EMDN Code
- M04010299 FIXING DRESSINGS - OTHER EUDAMED
- GMDN Term
- Electrode conductive medium FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1275 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ultradrape 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-10855683006545 | 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 59d64ada-2351-43bc-95dd-aefca6c9823e 61 fields · synced Jun 8, 2026
- FDA UDI 265912bd-eac2-4c3e-b9c7-6b038c306a37 35 fields · synced May 30, 2026