FDA UDI
In Commercial Distribution
🇺🇸 United States
Thermal Printer Kit, USB
DI: 00884838093928
·
Model: Thermal Printer Kit, USB
·
Philips Ds North America LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Thermal Printer Kit, USB
- Primary DI
- 00884838093928
- Version / Model
- Thermal Printer Kit, USB
- Catalog Number
- 989803205011
- Company Name
- Philips Ds North America LLC
- Labeler DUNS
- 013649151
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-11
- Public Version
- 2
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- 40613902-23fd-43af-97f4-0c91069a2399
Device Description
Non-MRI, Thermal Printer Kit, USB for MR Patient Care Portal 5000. Includes printer with USB cable and Power cable
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DSF | Recorder, Paper Chart | Cardiovascular | 870.2810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34937 | Paper chart recorder | A mains electricity (AC-powered) electronic device, which may include internal rechargeable batteries, intended to receive an input signal (e.g., from a physiological amplifier, signal conditioner, computer) which it converts and transcribes onto paper so that the information is stored in the form of a permanent document (hard copy). It will typically include a paper chart driven at constant speed by a motor and a pen(s) that moves back and forth in response to the signal, a printing array (e.g., thermal or electrostatic), or another device for printing on paper. It may be stationary or portable and will typically be used in the absence of a built-in chart recorder. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838093928 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 140 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 540 – 1010 millibar
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 405 – 758 Millimeter of Mercury
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 80 Percent (%) Relative Humidity