FDA UDI
In Commercial Distribution
🇺🇸 United States
Quelimmune
DI: G62102100601
·
Model: 02-1006-01
·
SEASTAR MEDICAL INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
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Basic Information
- Brand Name
- Quelimmune
- Primary DI
- G62102100601
- Version / Model
- 02-1006-01
- Catalog Number
- 02-1006-01
- Company Name
- SEASTAR MEDICAL INCORPORATED
- Labeler DUNS
- 100323889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2024-05-21
- Public Version
- 1
- Public Version Date
- 2024-05-29
- Public Version Status
- New
- Public Device Record Key
- a1504d2c-1fcd-4b7d-9645-749ae564a130
Device Description
Clinical Kit, SCD-PED
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QZV | Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47306 | Apheresis system column, selective leukocyte adsorption | A sterile cylinder containing an adsorptive carrier (e.g., cellulose acetate beads) for the adsorption of select leukocytes (e.g., granulocytes and monocytes/macropahges and mostly excluding lymphocytes, or the reverse) during apheresis. It is placed in an extracorporeal, closed-circuit apheresis system where blood is pumped from the patient, through the cylinder, and then back to the patient devoid of select leukocytes. It is typically used to treat a leukocyte-mediated condition [e.g., chronic inflammatory diseases such as inflammatory bowel disease (IBD) or rheumatoid arthritis (RA)] or to harvest select leukocytes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | G621021006011 | HIBCC | ||||
| Primary | G62102100601 | HIBCC |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 41 – 86 Degrees Fahrenheit