Identity
- Trade Name
- SAMI Cassette FDA UDI
- Generic Name
- Haemodialysis blood tubing set, single-use FDA UDI
- Device Name
- The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch. FDA UDI
- Model / Reference
- SA-400-00 FDA UDI
- Description
- The SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch. FDA UDI
Identifiers
- Catalog Number
- SA-400-00 FDA UDI
- Primary DI / UDI-DI
- 07540161930226 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Haemodialysis blood tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5860 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Haemodialysis blood tubing set, single-use
SAMI Cassette by I-Dialco Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis blood tubing set, single-use.
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- SAMI Hemofiltration Cassette — Dialco Medical Inc · Class II
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- NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET — NIPRO MEDICAL CORPORATION · Class II
- Nipro Set Blood Tubing Set — NIPRO MEDICAL CORPORATION · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
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
- I-Dialco Inc
Sources (1)
- FDA UDI d83fd453-750f-45d2-b6ad-8426f572642d 35 fields · synced May 31, 2026