Identity
- Trade Name
- Infusion Safety Products, Inc. FDA UDI
- Generic Name
- Vascular port administration set FDA UDI
- Device Name
- 20ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc FDA UDI
- Model / Reference
- ISP201Y FDA UDI
- Description
- 20ga x 1.00" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856673008184 FDA UDI
- 510(k) Number
- K170881 FDA UDI
- FDA Product Code
- PTI FDA UDI
- GMDN Term
- Vascular port administration set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
Category: Vascular port administration set
Infusion Safety Products, Inc. by Infusion Safety Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular port administration set.
- Port Access Needle — Bard Access Systems, Inc. · Class II
- VYGON — Vygon Corp. · Class II
- VYGON — Vygon Corp. · Class II
- Port Access Needle — Bard Access Systems, Inc. · Class II
- PowerLoc — Bard Access Systems, Inc. · Class II
- Port Access Kit — Bard Access Systems, Inc. · Class II
- PORT ACCESS INFUSION SET — SB-KAWASUMI LABORATORIES, INC. · Class II
- Port Access Kit — Bard Access Systems, Inc. · Class II
Cleared under the same submission
K170881 also covers:
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc.
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc.
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc.
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc.
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc.
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc.
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc.
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc.
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc.
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc.
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc.
- Infusion Safety Products, Inc. — Infusion Safety Products, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Infusion Safety Products, Inc.
Sources (1)
- FDA UDI 8651e136-7b7f-4c5d-8d0c-dba0ea23f68f 35 fields · synced May 30, 2026