FDA UDI
In Commercial Distribution
🇺🇸 United States
Basic disposable kit
DI: M896AMS3050
·
Model: AMS305
·
Arteriocyte Medical Systems, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Basic disposable kit
- Primary DI
- M896AMS3050
- Version / Model
- AMS305
- Catalog Number
- AMS305
- Company Name
- Arteriocyte Medical Systems, Inc.
- Labeler DUNS
- 809012870
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 5
- Public Version Date
- 2026-04-13
- Public Version Status
- Update
- Public Device Record Key
- 8a29bd51-ab52-4e19-89fb-675dca1d5524
Device Description
Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument
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
- Yes
- MRI Safety
- MR Safe
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46923 | Haematological concentrate system preparation kit, platelet concentration | A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M896AMS3051 | HIBCC | Box | 5 | In Commercial Distribution | |
| Primary | M896AMS3050 | HIBCC |
Customer Contacts
- Phone
- 866-660-2674
- [email protected]