FDA UDI
In Commercial Distribution
🇺🇸 United States
LifeFlow Rapid Infusion System
DI: B355FG50011
·
Model: FG5001
·
410 MEDICAL INNOVATION, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LifeFlow Rapid Infusion System
- Primary DI
- B355FG50011
- Version / Model
- FG5001
- Catalog Number
- FG5001
- Company Name
- 410 MEDICAL INNOVATION, LLC
- Labeler DUNS
- 050212206
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-11
- Public Version
- 4
- Public Version Date
- 2018-10-31
- Public Version Status
- Update
- Public Device Record Key
- 33a2e44a-4544-43e1-8bdb-f9c4de94bf11
Device Description
Rapid Infusion system including handle and sterile tubing set SA5101
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12170 | Intravenous administration tubing extension set | A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B355FG50011 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153731 | 000 |