FDA UDI
In Commercial Distribution
🇺🇸 United States
Braun
DI: 00328785000511
·
Model: PRO6000BSNAV2
·
KAZ USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Braun
- Primary DI
- 00328785000511
- Version / Model
- PRO6000BSNAV2
- Company Name
- KAZ USA, INC.
- Labeler DUNS
- 122612547
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-29
- Public Version
- 3
- Public Version Date
- 2020-05-27
- Public Version Status
- Update
- Public Device Record Key
- 42108f17-7ac4-421e-b12a-90e72923fcb7
Device Description
Braun Thermoscan PRO6000 Accessory Thermometry, Charging Station, to be used with PRO6000 ear thermometer.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 35396 | Thermometer holder | A device specifically designed to hold a patient thermometer. It can be, e.g., a small container to put the thermometer in or a holder affixed to, e.g., a wall upon which the thermometer is placed (housed). This device will often be considered to be an accessory to the GMDN code of the parent device. It is typically made of plastic, glass or metal and is used to protect the thermometer from damage and maintain it in a hygienic condition while it is not being used. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00328785000511 | GS1 | ||||
| Package | 10328785000518 | GS1 | Case | 30 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-535-6663
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 131 Degrees Fahrenheit