Duns Number:190094230
Device Description: HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn metal (Quinn P, Kerin JF, Warnes GM:Fertil Steril 1985;44:493-498). HTF HEPES uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
Catalog Number
2002-L
Brand Name
HTF HEPES
Version/Model Number
2002-L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K000939
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
22515b41-fddb-49e0-ae3c-d5876b02b798
Public Version Date
November 12, 2021
Public Version Number
1
DI Record Publish Date
November 04, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |