Identity
- Trade Name
- SecurePortIV FDA UDI
- Generic Name
- Wearable percutaneous catheter/tube holder FDA UDI
- Device Name
- SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. SP-015V50 unit box contains 50 SP-015V applicators FDA UDI
- Model / Reference
- SP-015V50 FDA UDI
- Description
- SecurePortIV is a catheter securement adhesive to be applied as a film forming securement and sealant at the point of vascular access catheter skin entry. SP-015V50 unit box contains 50 SP-015V applicators FDA UDI
Identifiers
- Catalog Number
- SP-015V50 FDA UDI
- Primary DI / UDI-DI
- M495SP015V502 FDA UDI
- 510(k) Number
- K170505 FDA UDI
- FDA Product Code
- NZP FDA UDI
- GMDN Term
- Wearable percutaneous catheter/tube holder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — .15 Milliliter FDA UDI
Category: Wearable percutaneous catheter/tube holder
SecurePortIV by Adhezion Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wearable percutaneous catheter/tube holder.
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- Cook — COOK INCORPORATED · Class I
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Cleared under the same submission
K170505 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
- Adhezion Biomedical, LLC
Sources (1)
- FDA UDI fb0d680f-c9c8-4cbd-a440-23df02164776 38 fields · synced Jun 6, 2026