INVOcell Retention Device

Primary DI: 00862190000341
Brand: INVOcell Retention Device
Company: INVO BIOSCIENCE, INC.
Model: P-017
Device description: The INVOcell Retention Device is a single-use, modified diaphragm that includes holes to allow for natural drainage of vaginal fluids. The retention device is placed into the vaginal cavity with the INVOcell Culture Device to ensure that the INVOcell Culture Device is retained in the vaginal cavity for 72 hours. The INVOcell Retention Device is a commercially-available diaphragm made of medical grade silicone.
Published: 2017-05-02
Public version status: Update
Distribution status: Not in Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: false
Single use: true

Product Codes#

Code, Name table
Code	Name
OYO	Culture, Intravaginal, Assisted Reproduction

Code, Device, Specialty table
Code	Device	Specialty	Class
OYO	Culture, Intravaginal, Assisted Reproduction	Obstetrics/Gynecology	2

Submission, Supplement table
Submission	Supplement
DEN150008	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
DEN150008	000	INVOcell	Invo Bioscience	2015-11-02	OYO

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00862190000341	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00862190000341	00862190000341	862190000341	0862190000341

Term, Definition table
Term	Definition
Assisted reproduction procedure dish	A sterile container intended for preparing and culturing gametes or embryos for use in assisted reproduction techniques (ART). Such techniques include in vitro fertilization (IVF), fertilization via intracytoplasmic sperm injection (ICSI), or other in IVF procedures. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in IVF. It is available in a variety of shapes and sizes, e.g., multi well dishes, Petri dishes, ICSI dishes and typically designed with an optically clear bottom for optimum manipulation and observation of ova and embryos. This is a single-use device.

Type, Low, High table
Type	Low	High	Condition
Special Storage Condition, Specify	0	0	Store away from moisture and direct heat
Storage Environment Temperature	0 Degrees Fahrenheit	77 Degrees Fahrenheit

Method table
Method

Primary DI, Brand, Model table
Primary DI	Brand	Model	Published
00862190000358	INVOcell Retention Device	P-011	2019-04-08
00862190000310	INVOcell Retention Device	P-010	2016-09-23
00862190000327	INVOcell Holding Block	P-007	2016-09-23
00862190000303	INVOcell Culture Device	FG-002	2016-09-23
00862190000334	INVOcell Culture Device	FG-002	2017-05-09

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00862190000358	INVOcell Retention Device	INVO BIOSCIENCE, INC.	OYO	2019-04-08
00862190000334	INVOcell Culture Device	INVO BIOSCIENCE, INC.	OYO	2017-05-09
00862190000303	INVOcell Culture Device	INVO BIOSCIENCE, INC.	OYO	2016-09-23
00862190000310	INVOcell Retention Device	INVO BIOSCIENCE, INC.	OYO	2016-09-23
00862190000327	INVOcell Holding Block	INVO BIOSCIENCE, INC.	OYO	2016-09-23