Identity
- Trade Name
- Smithworks Medical, Inc. FDA UDI
- Generic Name
- Personal device holder, reusable FDA UDI
- Device Name
- The Thermal Sack Pressure Infuser, also known as TSPI, is designed to be used with any of our iv fluid warmers as a thermal maintenance tool. The TSPI employs chemical hot packs to maintain target temperatures for up to an hour after deployment. There are no electronics within this device. FDA UDI
- Model / Reference
- TSPI05 FDA UDI
- Description
- The Thermal Sack Pressure Infuser, also known as TSPI, is designed to be used with any of our iv fluid warmers as a thermal maintenance tool. The TSPI employs chemical hot packs to maintain target temperatures for up to an hour after deployment. There are no electronics within this device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B964TSPI05 FDA UDI
- FDA Product Code
- LGZ FDA UDI
- GMDN Term
- Personal device holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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Convenience Kit
No
FDA UDI
Combination Product
No
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HCT/P
No
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Premarket Exempt
No
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Lot / Batch Number
No
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Serial Number
Yes
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Expiration Date
No
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Manufacturing Date
Yes
FDA UDI
Category: Personal device holder, reusableIntravenous pressure infusor, manual, reusable
Smithworks Medical, Inc. by Smithworks, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Smithworks, Inc.
Sources (1)
- FDA UDI 31809b58-edba-4509-ada8-9f2e193cd015 33 fields · synced May 30, 2026