FDA UDI
In Commercial Distribution
🇺🇸 United States
LipiGuard SB
DI: 10887691001243
·
Model: SB1E
·
HAEMONETICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- LipiGuard SB
- Primary DI
- 10887691001243
- Version / Model
- SB1E
- Company Name
- HAEMONETICS CORPORATION
- Labeler DUNS
- 057827420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 32780eed-751b-4321-ae35-fd5a42dcce5e
Device Description
LipiGuard SB Reinfusion Filter for Salvaged Blood
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 |
|---|---|---|---|---|
| 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 | 30887691001247 | GS1 | 40 | In Commercial Distribution | ||
| Primary | 10887691001243 | GS1 |
Customer Contacts
- Phone
- +1(800)-537-2802
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K960993 | 000 |