FDA UDI
In Commercial Distribution
🇺🇸 United States
BV Medical
DI: 00845821007407
·
Model: 41-009-000
·
BV Medical
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BV Medical
- Primary DI
- 00845821007407
- Version / Model
- 41-009-000
- Company Name
- BV Medical
- Labeler DUNS
- 105932508
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-06
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 977083eb-9cd2-4b68-b5ee-bb9483fe0773
Device Description
Probe Covers 100 per Box
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 13116 | Electronic thermometer probe cover | A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00845821028457 | GS1 | 200 | In Commercial Distribution | ||
| Package | 00845821028440 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00845821007407 | GS1 |
Customer Contacts
- Phone
- +1(888)822-8293
- [email protected]