SPERM WASH MEDIUM 2003-K2

GUDID 00859268006077

SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is 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 etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM 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 ID00859268006077
NIH Device Record Key4ef39785-3acf-443a-936d-59a56ca9ef88
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPERM WASH MEDIUM
Version Model Number2003-K2
Catalog Number2003-K2
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
GS100859268006077 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [SPERM WASH MEDIUM]

00859268006084SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum al
00859268006077SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum al
00859268006060SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum al
00859268006053SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum al
00859268006039SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum al
00859268006282SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum al

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