FDA UDI
Not in Commercial Distribution
🇺🇸 United States
enFlow
DI: 10885403286162
·
Model: 980202EU
·
Carefusion Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- enFlow
- Primary DI
- 10885403286162
- Version / Model
- 980202EU
- Catalog Number
- 980202EU
- Company Name
- Carefusion Corporation
- Labeler DUNS
- 830432451
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2024-05-21
- Public Version Status
- Update
- Public Device Record Key
- b85c08fe-d71a-4334-9281-12ac92d00249
- Distribution End Date
- 2022-03-31
Device Description
enFlow™ Disposable IV Fluid/Blood Warmer Cartridge With IV Extension Model 200
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
- 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 |
|---|---|---|---|---|
| 47619 | Convection blood/fluid warmer set | A collection of devices used in conjunction with a convection blood/fluid warmer to heat banked blood, blood products, and intravenous (IV) fluids to a temperature appropriate for infusion into a patient. It may consist of coiled tubing, or other design, 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 | 50885403286160 | GS1 | Case | 10 | Not in Commercial Distribution | 2022-03-31 |
| Package | 20885403286169 | GS1 | Box | 10 | Not in Commercial Distribution | 2022-03-31 |
| Primary | 10885403286162 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 70 Degrees Celsius