FDA UDI
In Commercial Distribution
🇺🇸 United States
Patient Support & Fixation
DI: 00887761971950
·
Model: 1582709
·
Baxter Medical Systems GmbH + Co. KG
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Patient Support & Fixation
- Primary DI
- 00887761971950
- Version / Model
- 1582709
- 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
- e829182d-1db9-4941-a56b-d48c982b965a
Device Description
Belt for patients X-TRA
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 |
|---|---|---|---|---|
| GDC | TABLE, OPERATING-ROOM, ELECTRICAL | General, Plastic Surgery | 878.4960 | 1 |
| JEA | TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED | General, Plastic Surgery | 878.4960 | 1 |
| KXJ | Table, radiologic | Radiology | 892.1980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15325 | Patient positioning vacuum pad | A device designed to position and immobilize parts of the patient (e.g., head, extremities) typically during therapeutic interventions or patient transportation. The device immobilizes a body part by encompassing it and then applying a vacuum. The device is typically an airtight soft pillow case type of covering made of flexible materials, e.g., plastic or rubber. When sealed, this device retains the shape of the part that it encompasses until the vacuum is released. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887761971950 | GS1 |
Customer Contacts
- Phone
- +4936715860
- [email protected]