FDA UDI
In Commercial Distribution
🇺🇸 United States
Fisherbrand
DI: 00613647024683
·
Model: FSSWB15/EMD
·
FISHER SCIENTIFIC COMPANY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fisherbrand
- Primary DI
- 00613647024683
- Version / Model
- FSSWB15/EMD
- Catalog Number
- S35882
- Company Name
- FISHER SCIENTIFIC COMPANY L.L.C.
- Labeler DUNS
- 004321519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-21
- Public Version
- 1
- Public Version Date
- 2022-09-29
- Public Version Status
- New
- Public Device Record Key
- f321c6f2-284e-442e-9356-82e832620ee5
Device Description
ISOTEMP 15L SHAKING BATH
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JTQ | BATH, INCUBATORS/WATER, ALL | Microbiology | 866.2540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16772 | Laboratory water bath/shaker | A mains electricity (AC-powered) device designed with a heating element, thermostat and an automated shaking mechanism to heat and shake its contents (i.e., the water and objects placed therein, e.g., bottles containing cultures or trays of gel). This device has an eccentic agitation arm that rotates at speed ranges of, e.g., 25 - 400 revolutions per minute (rpm) to create the agitation. It may incorporate a range of features such as automatic water replenishment, heating and/or cooling, automatic motion acceleration to avoid unwanted splashing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613647024683 | GS1 |
Customer Contacts
- Phone
- +1(724)517-2425
- [email protected]