ORIGIO Gradient 40/80
- Primary DI
- 60888937029415
- Company
- Coopersurgical, Inc.
- Model
- 84022060M
- Device description
- ORIGIO Gradient 40/80, 2x60 ml
- Published
- 2026-02-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- false
Regulatory Flags
- DUNS number
- 801895244
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 60888937029415 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 60888937029415 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| MQL | Media, Reproductive | 2 | Obstetrics/Gynecology | 884.6180 | N | Eligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K153267 | 000 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash | Origio A/S | 2016-07-22 | MQL |
GMDN Terms
| Term | Definition |
|---|
| IVF medium kit | A collection of solutions used to provide a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solutions typically contain various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). Some included solutions may indirectly support the IVF process. This is a single-use device. |
Device Sizes
No records found.
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Protect from light |
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Contacts
No records found.
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 60888937029798 | ORIGIO Gradient 90 w/o Gentamicin | Coopersurgical, Inc. | MQL | 2026-03-12 |
| 00859500005325 | FemSperm No Analysis | FEMASYS INC. | MQL | 2026-02-06 |
| 00859500005356 | FemSperm No Analysis | FEMASYS INC. | MQL | 2026-02-06 |
| 00888937028331 | ORIGIO Sequential Blast | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028348 | ORIGIO Sequential Blast | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028355 | ORIGIO Sequential Blast | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028386 | ORIGIO Sequential Cleav | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028393 | ORIGIO Sequential Cleav | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028409 | ORIGIO Sequential Cleav | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028416 | ORIGIO Sequential Cleav | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028430 | ORIGIO Sequential Fert | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028447 | ORIGIO Sequential Fert | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028454 | ORIGIO Sequential Fert | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028461 | ORIGIO Sequential Fert | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028607 | SynVitro Flush | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028959 | Origio Handling | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028966 | Origio Handling | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028973 | Origio Handling | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937028980 | Origio Handling | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937029116 | SAGE 1-Step | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937029123 | SAGE 1-Step | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 60888937029330 | ORIGIO Sperm Wash | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 60888937029361 | ORIGIO Gradient 100 | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937029383 | ORIGIO Gradient 90 | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937833041 | SAGE 1-Step | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937027921 | SynVitro Hyadase | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 00888937029970 | ICSI Cumulase | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 60888937028203 | IVM System | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 60888937029194 | MC Vitrification Cooling | Coopersurgical, Inc. | MQL | 2026-02-05 |
| 60888937029200 | MC Vitrification Warming | Coopersurgical, Inc. | MQL | 2026-02-05 |