FDA UDI
In Commercial Distribution
🇺🇸 United States
Smithworks Medical, Inc.
DI: B96412VPK3L12
·
Model: 12VPK3L12
·
Smithworks, Inc.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Smithworks Medical, Inc.
- Primary DI
- B96412VPK3L12
- Version / Model
- 12VPK3L12
- Company Name
- Smithworks, Inc.
- Labeler DUNS
- 009796074
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-08
- Public Version
- 1
- Public Version Date
- 2024-04-16
- Public Version Status
- New
- Public Device Record Key
- 251b26e3-0ad5-4bd5-a62b-a00864559603
Device Description
PAK2-P IV fluid warmer
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LGZ | Warmer, Thermal, Infusion Fluid | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40516 | Multi-purpose warming cabinet, stationary | A mains electricity (AC-powered) device designed to warm various items and products prior to use, e.g., bags of irrigation or intravenous (IV) solutions, blankets or clothing to cover or put onto a patient, or clothing for the operating room (OR) personnel to adorn. It typically consists of a heat insulated enclosure with a sealing door, shelves, heating element(s), a thermostat and operating controls. This is a freestanding cabinet (tabletop or floor design) that is designed to be stationary and used in one location. It may also be used in a laboratory. | No | Active |
| 66194 | Intravenous fluid storage/warming bag | An electrically-powered device in the form of an insulated bag designed to store intravenous (IV) infusion bags and heat the IV solutions they contain to near body temperature before infusion; it is typically intended for use in an ambulance. It includes pouches to place the IV infusion bags, a heated metallic insert, and a temperature controller. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B96412VPK3L12 | HIBCC |