FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells
DI: 00857515006047
·
Model: 99418-90mL
·
FUJIFILM IRVINE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells
- Primary DI
- 00857515006047
- Version / Model
- 99418-90mL
- Catalog Number
- 99418
- Company Name
- FUJIFILM IRVINE SCIENTIFIC, INC.
- Labeler DUNS
- 057475246
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-31
- Public Version
- 4
- Public Version Date
- 2022-02-25
- Public Version Status
- Update
- Public Device Record Key
- 12c32686-c849-4a71-b734-b3da941c6f4a
- Distribution End Date
- 2022-02-24
Device Description
Chang Medium C with Gentamicin 99418-90mL is longer being sold on its own. It can now only be purchased as part of the 99419-100ml kit.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | Hematology | 864.2220 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60095 | Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent | A substance or reactant intended to be used for the suspension, preservation and storage of amnioic fluid and/or chorionic villus sample (CVS) fluid of a clinical specimen, in order to maintain suitability for karyotyping or chromosome evaluation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857515006047 | GS1 |
Customer Contacts
- Phone
- 8004375706
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 90 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius