Dmem (Dulbecco’s Modified Eagle Medium)
24 catalogue numbers from 10569010, listed by Life Technologies Corporation, United States, under Media, Culture, Ex Vivo, Tissue And Cell. 1 manufacturer in China is registered for this product code.
1manufacturer
24catalogue numbers in this listing
4510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yocon Biology Technology Company | Haidian | Beijing | Manufacturer | 2 |
Record
| Listed by | Life Technologies Corporation, United States |
|---|---|
| FDA product code | NDS |
| Device type | Media, Culture, Ex Vivo, Tissue And Cell |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5885 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-08-01 |
| Record revised | 2024-04-30 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Protect from light |
| Packaging | Case of 10, case of 6 |
| Distribution end date | 2024-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10569010 | Withdrawn | |
| 11965167 | Withdrawn | |
| 10569069 | Withdrawn | |
| 10564011 | Withdrawn | |
| 10564037 | Withdrawn | |
| 11885076 | Withdrawn | |
| 11965092 | Withdrawn | |
| 10313021 | Withdrawn | |
| 10564045 | Withdrawn | |
| 11995065 | Withdrawn | |
| 11995115 | Withdrawn | |
| 11995123 | Withdrawn | |
| 11885084 | Withdrawn | |
| 10569077 | Withdrawn | |
| 11995040 | Withdrawn | |
| 10566032 | Withdrawn | |
| 10567014 | Withdrawn | |
| 11960051 | Withdrawn | |
| 12430047 | Withdrawn | |
| 12430054 | Withdrawn | |
| 12320032 | Withdrawn | |
| 10566016 | Withdrawn | |
| 11965175 | Withdrawn | |
| 11965084 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gibco® CTS™ AIM V® SFM | Life Technologies Corporation | 2 |
| OpTmizer™ CTS™ T-Cell Expansion Basal Medium | Life Technologies Corporation | 2 |
| Gibco | Life Technologies Corporation | 2 |
| KnockOut™ SR Xenofree CTS™ | Life Technologies Corporation | 2 |
| KnockOut™ Serum Replacement | Life Technologies Corporation | 2 |
| CTS™ AIM-V™ Medium | Life Technologies Corporation | 2 |
| CTS™ OpTmizer™ T-Cell Expansion Basal Medium | Life Technologies Corporation | 2 |
| CTS™ OpTmizer™ T-Cell Expansion Supplement | Life Technologies Corporation | 1 |
| Stemproò MSC SFM Basal Medium CTS™ | Life Technologies Corporation | 1 |
| OpTmizer™ CTS™ T-Cell Expansion Supplement | Life Technologies Corporation | 1 |
| Dmem (1X) Dulbecco’s Modified Eagle Medium | Life Technologies Corporation | 1 |
| Stemproò MSC SFM Supplement CTS™ | Life Technologies Corporation | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113566 | 2012-06-21 |
| K103302 | 2011-02-18 |
| K100616 | 2010-05-20 |
| DEN000008 | 2001-02-16 |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-06-11 | Class II | Vendor change control | Component was not tested by the supplier for adventitious agents | 4724 Kits | 2020-06-04 |
| 2018-05-10 | Class II | Unknown/Undetermined by firm | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subs | 91 | 2020-05-05 |
| 2018-05-10 | Class II | Unknown/Undetermined by firm | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subs | 70 | 2020-05-05 |
| 2018-05-10 | Class II | Unknown/Undetermined by firm | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subs | 10 | 2020-05-05 |
| 2018-05-10 | Class II | Unknown/Undetermined by firm | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subs | 45 | 2020-05-05 |
| 2018-05-10 | Class II | Unknown/Undetermined by firm | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subs | 141 | 2020-05-05 |
| 2018-05-10 | Class II | Unknown/Undetermined by firm | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subs | Updated as of 6/21/19: 6304 units | 2020-05-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.