FDA UDI
In Commercial Distribution
🇺🇸 United States
Multiroom IVF incubator
DI: 04779041940212
·
Model: MIRI
·
ESCO MEDICAL TECHNOLOGIES UAB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Multiroom IVF incubator
- Primary DI
- 04779041940212
- Version / Model
- MIRI
- Company Name
- ESCO MEDICAL TECHNOLOGIES UAB
- Labeler DUNS
- 365831125
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-15
- Public Version
- 1
- Public Version Date
- 2026-01-23
- Public Version Status
- New
- Public Device Record Key
- ec535b63-72c3-4c69-8201-7904c8cff962
Device Description
The Esco Medical MIRI® family’s multiroom IVF incubators are intended to be used to provide a stable culture environment at or near body temperature and CO2/N2 or premixed gases and humidification for the development of gametes and embryos during in vitro fertilization (IVF)/assisted reproduction technology (ART) treatments.
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 |
|---|---|---|---|---|
| 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 | 04779041940212 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133742 | 000 |