FDA UDI
In Commercial Distribution
🇺🇸 United States
K-Systems
DI: 05060554120956
·
Model: G210 InviCell
·
RESEARCH INSTRUMENTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- K-Systems
- Primary DI
- 05060554120956
- Version / Model
- G210 InviCell
- Catalog Number
- K59500
- Company Name
- RESEARCH INSTRUMENTS LIMITED
- Labeler DUNS
- 536139413
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-25
- Public Version
- 1
- Public Version Date
- 2025-03-05
- Public Version Status
- New
- Public Device Record Key
- 2e138a93-4edf-4e1b-8998-afdec5ea9ffc
Device Description
IVF Incubator. Intended to establish a suitable environment for the development of human embryos/blastocysts for the in vitro fertilization (IVF)/assisted reproductive technology (ART) procedures.
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PUB | Accessory, Assisted Reproduction, Exempt | Obstetrics/Gynecology | 884.6120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44290 | Assisted reproduction heater/incubator | An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060554120956 | GS1 |