FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Complete MultiBlast Medium® with SSS
DI: 00893727002279
·
Model: 90141-2X20mL
·
FUJIFILM IRVINE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Complete MultiBlast Medium® with SSS
- Primary DI
- 00893727002279
- Version / Model
- 90141-2X20mL
- Catalog Number
- 90141
- Company Name
- FUJIFILM IRVINE SCIENTIFIC, INC.
- Labeler DUNS
- 057475246
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-09-10
- Public Version
- 4
- Public Version Date
- 2019-02-13
- Public Version Status
- Update
- Public Device Record Key
- ab8e5e26-c2aa-4511-bc72-8abdb03debb8
- Distribution End Date
- 2017-06-30
Device Description
Complete MultiBlast With SSS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQL | Media, Reproductive | Obstetrics/Gynecology | 884.6180 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44046 | IVF medium | A solution that provides 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 solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00893727002279 | GS1 | ||||
| Unit of Use | 18937270022793 | GS1 |
Customer Contacts
- Phone
- 8004375706
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K034063 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 20 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius