FDA UDI
In Commercial Distribution
🇺🇸 United States
HAEMONETICS ACP 215 SYSTEM
DI: 10812747015028
·
Model: 00236-00
·
HAEMONETICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HAEMONETICS ACP 215 SYSTEM
- Primary DI
- 10812747015028
- Version / Model
- 00236-00
- Company Name
- HAEMONETICS CORPORATION
- Labeler DUNS
- 057827420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-07
- Public Version
- 4
- Public Version Date
- 2023-10-19
- Public Version Status
- Update
- Public Device Record Key
- cc724c0e-ea97-4aee-b638-a9fcd778668f
Device Description
RBC DE-GLYCEROL. SET 325ML BMB
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
- 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 |
|---|---|---|---|---|
| KSW | SYSTEM, PROCESSING FOR FROZEN BLOOD | Hematology | 864.9145 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45520 | Blood cell freeze/thaw system set | A sterile collection of devices intended to be used in a blood cell processing system to either prepare red blood cells for frozen storage (glycerolization), or deglycerolize and wash red blood cells after thawing (may also wash fresh red blood cells). The device typically consists of a bacteriological filter, solution lines, connection ports, and collection containers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30812747015022 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 10812747015028 | GS1 |
Customer Contacts
- Phone
- +1(800)-537-2802
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK030062 | 0 |
| BK040077 | 0 |
| BK060008 | 0 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 5 | Liter | |
| Total Volume | 325 | Milliliter | |
| Total Volume | 600 | Milliliter |