FDA UDI
In Commercial Distribution
🇺🇸 United States
Thermo Scientific Forma
DI: 10815773020189
·
Model: 7457
·
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Thermo Scientific Forma
- Primary DI
- 10815773020189
- Version / Model
- 7457
- Catalog Number
- 7457
- Company Name
- THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
- Labeler DUNS
- 791530061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 91538f64-892b-4dd6-b3e2-d56f09372a46
Device Description
Controlled Rate Freezer
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
- 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
- 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 |
|---|---|---|---|---|
| MQG | Accessory, Assisted Reproduction | Obstetrics/Gynecology | 884.6120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44622 | Assisted reproduction freezer | A mains electricity (AC-powered) device designed to provide suitable cold storage conditions for reproductive biological materials (e.g., gametes, embryos) at closely regulated and monitored temperatures. It will typically use liquid nitrogen (LN2) to create cold temperatures, as well as an electrical heater and air circulating fan for temperature control. It will typically have an integral alarm system to warn against temperature variations and breaks in the mains power supply. This device is typically not intended for long-term storage. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10815773020189 | GS1 |
Customer Contacts
- Phone
- 1-800-438-4851
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021042 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Indoor use only