FDA UDI
In Commercial Distribution
🇺🇸 United States
HAEMONETICS CELL SAVER 5/5+ SYSTEMS
DI: 10812747016285
·
Model: 0291E-00
·
HAEMONETICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HAEMONETICS CELL SAVER 5/5+ SYSTEMS
- Primary DI
- 10812747016285
- Version / Model
- 0291E-00
- Company Name
- HAEMONETICS CORPORATION
- Labeler DUNS
- 057827420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 5
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- e798f215-25b3-4c60-a91e-0017e06d0320
Device Description
CELL SAVER 5/5+ BOWL KIT-70ML
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 |
|---|---|---|---|---|
| CAC | Apparatus, Autotransfusion | Anesthesiology | 868.5830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17605 | Autotransfusion system blood component processing set | A collection of noninvasive devices that typically includes tubing, containers (e.g., bags or bowls for treatment, reinfusion, waste disposal) and filters intended to be used to process (filter/wash) blood components (e.g., red or white blood cells, platelets) in conjunction with a dedicated pump (not included) as part of an autotransfusion procedure; it is not dedicated to suction and/or anticoagulation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30812747016289 | GS1 | Carton | 8 | In Commercial Distribution | |
| Primary | 10812747016285 | GS1 |
Customer Contacts
- Phone
- +1(800)-537-2802
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K014083 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 70 | Milliliter | |
| Total Volume | 1000 | Milliliter | |
| Total Volume | 5 | Liter |