FDA UDI
In Commercial Distribution
🇺🇸 United States
LCG2b with AS-1, AS-3 and AS-5
DI: 03567050035347
·
Model: KSV
·
MACO PRODUCTIONS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LCG2b with AS-1, AS-3 and AS-5
- Primary DI
- 03567050035347
- Version / Model
- KSV
- Catalog Number
- KSV0004XD
- Company Name
- MACO PRODUCTIONS
- Labeler DUNS
- 265492868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7294307a-0a17-4ad9-94e8-b3442db6bf8b
Device Description
Leucolab LCG2b Leukoreduction System for Red Blood Cells. The Leucolab LCG2b product consists of a transfer line, drip chamber, leukoreduction filter, by-pass tubing and transfer bag. It is sterilized by electron beam (beta irradiation) and is supplied with sterile and non-pyrogenic fluid pathways.
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
- 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 |
|---|---|---|---|---|
| CAK | Microfilter, Blood Transfusion | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44033 | Blood donor set, single-pack | An assembly of sterile devices intended to be used to collect whole blood from a donor. It includes a container (a single flexible bag) with anticoagulation solution, tubing, and an attached needle for venipuncture. It may include integrated features such as an in-line leukocyte filter, pre-donation blood sampling device, and/or needle stick prevention device. After collection, the blood is tested, stored, and infused from the container when needed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 13567050035344 | GS1 | Carton | 15 | In Commercial Distribution | |
| Primary | 03567050035347 | GS1 |
Customer Contacts
- Phone
- 770-270-6867
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK120071 | 0 |