FDA UDI
In Commercial Distribution
🇺🇸 United States
TRITON
DI: 00859506006128
·
Model: FG-12010
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TRITON
- Primary DI
- 00859506006128
- Version / Model
- FG-12010
- Catalog Number
- FG-12010
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 196548481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-25
- Public Version
- 6
- Public Version Date
- 2024-02-08
- Public Version Status
- Update
- Public Device Record Key
- fe01004e-5384-4fa9-b184-809b1b338b77
Device Description
TRITON 2L CANISTER INSERT KIT
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PBZ | Image Processing Device For Estimation Of External Blood Loss | General Hospital | 880.2750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61697 | Blood loss estimation canister insert/label | A device in the form of a shaped plastic insert or an adhesive sticker intended to be placed in and/or on a surgical suction system canister to facilitate estimation of the quantity of external blood loss during a surgical procedure. It provides a uniform background and standardization of ambient lighting conditions to improve the quality of images taken by a device that runs blood loss estimation application software. The label may also be used as a device identifier. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859506006128 | GS1 | ||||
| Package | 10859506006125 | GS1 | pack | 50 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid exposure to ultraviolet light