FDA UDI
In Commercial Distribution
🇺🇸 United States
SURETRANS
DI: 00801741065415
·
Model: 8592000
·
Davol Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- SURETRANS
- Primary DI
- 00801741065415
- Version / Model
- 8592000
- Catalog Number
- 8592000
- Company Name
- Davol Inc.
- Labeler DUNS
- 001191048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-06-17
- Public Version
- 5
- Public Version Date
- 2024-10-22
- Public Version Status
- Update
- Public Device Record Key
- 41651ccd-8d28-4713-bf6e-849ece5ac2e6
- Distribution End Date
- 2027-12-28
Device Description
SureTrans Autotransfusion System for Orthopaedics with PVC Drain and 2 Trocars
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
- No
- 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 |
|---|---|---|---|---|
| 46263 | Whole-blood-recovery autotransfusion system, manual | An assembly of manual devices intended to be used to collect, filter, and reinfuse intraoperative and/or postoperative autologous blood shed during and/or after surgery. It is a closed-circuit system that typically includes a manual aspiration (suction) pump, a collection container, reinfusion bag, safety clamps, non-return valves, blood screening filters, and a transfusion set; a drain(s) and/or trocar(s) may also be included in the system. It may facilitate connection to the wall outlet of a vacuum system for aspiration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741065412 | GS1 | CA | 6 | In Commercial Distribution | 2027-12-28 |
| Primary | 00801741065415 | GS1 | ||||
| Package | 20801741065419 | GS1 | BX | 3 | In Commercial Distribution | 2027-12-28 |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 4.7 | Millimeter |