FDA UDI
In Commercial Distribution
🇺🇸 United States
Temperature Sensor Probe, 18G x 20cm
DI: 00810563022322
·
Model: ABL-18TP20
·
Varian Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Temperature Sensor Probe, 18G x 20cm
- Primary DI
- 00810563022322
- Version / Model
- ABL-18TP20
- Company Name
- Varian Medical Systems, Inc.
- Labeler DUNS
- 118097024
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-09
- Public Version
- 2
- Public Version Date
- 2025-10-06
- Public Version Status
- Update
- Public Device Record Key
- 478bb7dd-d1c0-40f7-91b2-dbfc458e0e62
Device Description
Ablation accessory: disposable temperature probe, 18G/20cm Probe QTY 1
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NEY | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36562 | Patient monitoring system module, temperature | A small unit dedicated to the measurement and display of the patient's body temperature at one or more body sites. Signals are typically obtained through connected temperature probes, e.g., skin, rectal. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the body temperature information measured and provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810563022329 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00810563022322 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240784 | 000 |