FDA UDI
In Commercial Distribution
🇺🇸 United States
ICU Medical
DI: 00887709013247
·
Model: B9220
·
ICU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ICU Medical
- Primary DI
- 00887709013247
- Version / Model
- B9220
- Company Name
- ICU MEDICAL, INC.
- Labeler DUNS
- 118380146
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-18
- Public Version
- 5
- Public Version Date
- 2020-11-19
- Public Version Status
- Update
- Public Device Record Key
- 2eeab901-4579-4dbc-a706-c9c5d475627c
Device Description
84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave®, Rotating Luer
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| FJK | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38569 | Blood transfusion set, non-exchange | An intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10887709013244 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00887709013247 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983559 | 000 |