FDA UDI
In Commercial Distribution
🇺🇸 United States
Boekel Small Platelet Agitator
DI: 00863626000218
·
Model: 301200
·
BOEKEL INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Boekel Small Platelet Agitator
- Primary DI
- 00863626000218
- Version / Model
- 301200
- Catalog Number
- 301200
- Company Name
- BOEKEL INDUSTRIES, INC.
- Labeler DUNS
- 002288215
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-16
- Public Version
- 1
- Public Version Date
- 2019-05-24
- Public Version Status
- New
- Public Device Record Key
- 2fa7a85a-d7a6-4c4b-887d-ce5f7c9e7c56
Device Description
Device used to agitate platelets. May be used alone if temperature can be maintained to 22 degrees C +/- 2 degrees. may be used in conjunction with the Boekel Small Platelet Incubator.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KSQ | Device, Blood Mixing And Blood Weighing | Hematology | 864.9195 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45226 | Platelet agitator | A mains electricity (AC-powered), electromechanical device typically used by blood bank and transfusion services to provide gentle agitation (e.g., side-to-side motion) required for platelet storage. The device will typically provide several drawers on which to place containers of platelets. It may include an audible alarm that sounds if agitation does not occur during use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00863626000218 | GS1 |