FDA UDI
In Commercial Distribution
🇺🇸 United States
Fluido® AirGuard System
DI: 08719867002752
·
Model: 671500-US
·
The Surgical Company International B.V.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Fluido® AirGuard System
- Primary DI
- 08719867002752
- Version / Model
- 671500-US
- Company Name
- The Surgical Company International B.V.
- Labeler DUNS
- 409656493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-12
- Public Version
- 1
- Public Version Date
- 2025-09-22
- Public Version Status
- New
- Public Device Record Key
- b1b89976-029c-4d67-867c-4da8115fd5dd
Device Description
Fluido® Trauma Set US
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 47622 | Radiation blood/fluid warmer intravenous set | A collection of devices used in conjunction with a radiation blood/fluid warmer to heat banked blood, blood products, and intravenous (IV) fluids to a temperature appropriate for infusion into a patient. It typically consists of a pouch(es) or a flexible cassette through which blood/fluid flows from the infusion bag to the patient while being heated in-line by the warmer; clamps and a bubble trap may be included. The set is typically used in the operating room (OR) or in accident and emergency (A&E) situations when rapid infusion of several units of blood/fluid is necessary. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08719867002769 | GS1 | Inner Box | 15 | In Commercial Distribution | |
| Primary | 08719867002752 | GS1 | ||||
| Package | 08719867002776 | GS1 | Outer Box | 30 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251733 | 000 |