FDA.reportPublic FDA data

Smithworks Medical, Inc.

Primary DI
B964TSPI05
Brand
Smithworks Medical, Inc.
Company
Smithworks, Inc.
Model
TSPI05
Device 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.
Published
2024-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B964TSPI05PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, reusableA portable device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, strap, belt, or clothing, or as a trolley with wheels. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009796074
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B96412VFM4L02Smithworks Medical Inc.12VFM4L022024-04-08
B96412VPK2L02Smithworks Medical, Inc12VPK2L02-C2024-04-08
B96412VPK3L12Smithworks Medical, Inc.12VPK3L122024-04-08
B96412VSS3L02Smithworks Medical, Inc.12VSS3L022024-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00841027104759Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
07540162042867HugAire 2 Cu.Ft.Single Compartment Warming CabinetImperial Surgical LtdLGZ2026-04-24
00724995153724AmscoSTERIS CORPORATIONLGZ2026-02-13
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00841027101604Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
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00841027102311Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
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00841027102342Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102359Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102366Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102373Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102380Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102397Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102403Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08