FDA UDI
In Commercial Distribution
🇺🇸 United States
Kryo
DI: B199GDKRYO570CH1150
·
Model: GDKRYO570-CH-115
·
PLANER LIMITED
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Kryo
- Primary DI
- B199GDKRYO570CH1150
- Version / Model
- GDKRYO570-CH-115
- Company Name
- PLANER LIMITED
- Labeler DUNS
- 217190495
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-22
- Public Version
- 1
- Public Version Date
- 2024-10-30
- Public Version Status
- New
- Public Device Record Key
- 20df913c-837a-4f4f-ad0e-42c4bf9858b0
Device Description
Kryo570 Freezer Chamber, 16 litre, 115V
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
- Yes
- 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 |
|---|---|---|---|---|
| KSP | Apparatus, Cell-Freezing And Reagents | Hematology | 864.9225 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35829 | Freezer control unit, programmable | A mains electricity (AC-powered) unit used together with a specific freezer where it is important that a certain predetermined freezing pattern is followed in order to preserve the contents of the freezer. This pattern may differ according to various considerations, e.g., lowering of temperature by steps over a given time. A pre-set program will be imposed upon the freezer. | No | Active |
| 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 | B199GDKRYO570CH1150 | HIBCC |