FDA UDI
In Commercial Distribution
🇺🇸 United States
Control Units
DI: 00887761968677
·
Model: 1997423
·
Baxter Medical Systems GmbH + Co. KG
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Control Units
- Primary DI
- 00887761968677
- Version / Model
- 1997423
- Company Name
- Baxter Medical Systems GmbH + Co. KG
- Labeler DUNS
- 330961223
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-27
- Public Version
- 2
- Public Version Date
- 2023-02-09
- Public Version Status
- Update
- Public Device Record Key
- 036df316-36ae-4abf-b77c-4afc32264b90
Device Description
TruSystem 7500 SensorLine Premium
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JEA | TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED | General, Plastic Surgery | 878.4960 | 1 |
| KXJ | Table, radiologic | Radiology | 892.1980 | 2 |
| GDC | TABLE, OPERATING-ROOM, ELECTRICAL | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61586 | Operating room equipment remote control | A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an operating table (e.g., orthopaedic operating table, ophthalmic operating table), lights, and/or cameras in the operating room (OR) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887761968677 | GS1 |
Customer Contacts
- Phone
- +4936715860
- [email protected]