FDA UDI
In Commercial Distribution
🇺🇸 United States
Donor Doc
DI: 00812747010200
·
Model: 3.x.x
·
HAEMONETICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Donor Doc
- Primary DI
- 00812747010200
- Version / Model
- 3.x.x
- Company Name
- HAEMONETICS CORPORATION
- Labeler DUNS
- 057827420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-27
- Public Version
- 1
- Public Version Date
- 2018-08-27
- Public Version Status
- New
- Public Device Record Key
- 02d3151a-12ce-422a-beae-b2ca2d292ef6
Device Description
Donor Doc version 3.x.x
Device Characteristics
- Single Use
- No
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MMH | Blood Establishment Computer Software and Accessories | Hematology | 864.9165 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60065 | Configurable electronic form web-based application software | An application software program designed as an Internet-based information system intended to replace paper forms by electronically collecting and recording all types of patient clinical information, investigation results, and treatment data. It is a generic system which can be used in healthcare by configuration of workflows, metadata, and data lifecycles; and by integration into electronic medical record (EMR) systems using standard protocols. The electronic forms are intended to provide predefined workflow, input, search, and display functionalities, typically to manage a particular treatment or condition [e.g., hyposensitization (allergy desensitization), cleft lip]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812747010200 | GS1 |
Customer Contacts
- Phone
- +1(800)-537-2802
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK140183 | 0 |