HTF HEPES 2002-L

GUDID 00859268006275

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.

INVITROCARE, INCORPORATED

IVF medium
Primary Device ID00859268006275
NIH Device Record Key22515b41-fddb-49e0-ae3c-d5876b02b798
Commercial Distribution StatusIn Commercial Distribution
Brand NameHTF HEPES
Version Model Number2002-L
Catalog Number2002-L
Company DUNS190094230
Company NameINVITROCARE, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859268006275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQLMedia, Reproductive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-12
Device Publish Date2021-11-04

On-Brand Devices [HTF HEPES]

00859268006022HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive techn
00859268006015HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive techn
00859268006275HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive techn

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