Amazrock
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Basic Information
- Brand Name
- Amazrock
- Primary DI
- 08883000001749
- Version / Model
- Amaz-HC1001401
- Company Name
- AMAZROCK PTE. LTD.
- Labeler DUNS
- 659258748
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-30
- Public Version
- 5
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- c7161f12-33e3-4a1c-8c88-d9156a8168f8
- Distribution End Date
- 2018-04-06
Device Description
AMAZROCK Digital Infrared Thermometer Dual Mode supports temperature scan via Forehead or Eardrum Detection. It is designed for use with adults and children. Modern Design & Convenient to Use - Ergonometric design to facilitate easy use across all ages. - The back-light screen makes it very convenient to use at night or under dim lighting conditions. - Rapid and accurate reading with 1 second measurement time. - Forehead scan mode makes it convenient to measure temperature while your child is sleeping. - Eardrum temperature detection mode is only suitable for use for ages 3 months & above. - Easy & Comfortable use experience as compared with other thermometer(s). Simple operations with just 2 buttons - “Head” (Forehead temperature detection) or “Ear” (Eardrum temperature scan). - Supports 20 readings memory recall. - Comes with two AAA batteries for immediate use.
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
- No
- 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 |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17888 | Infrared patient thermometer, skin | A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08883000001749 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131243 | 000 |