Identity
- Trade Name
- Dale Catheter Securement Device FDA UDI
- Generic Name
- Wearable percutaneous catheter/tube holder FDA UDI
- Device Name
- Dale IV Start Kit FDA UDI
- Model / Reference
- 851 FDA UDI
- Description
- Dale IV Start Kit FDA UDI
Identifiers
- Catalog Number
- 851 FDA UDI
- Primary DI / UDI-DI
- 00817612020148 FDA UDI
- FDA Product Code
- KMK FDA UDI
- GMDN Term
- Wearable percutaneous catheter/tube holder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5210 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Dale Catheter Securement Device by Dale Medical Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Dale Medical Products, Inc.
Sources (1)
- FDA UDI 68a6c6d9-1237-4f71-9899-ad5b893ade56 36 fields · synced Jun 9, 2026