LIFEGLOBAL GROUP, LLC

Address:393 Soundview Rd,GUILFORD,CT,06437,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

ACCESSORY, ASSISTED REPRODUCTION (MQG) (9) MICROMANIPULATORS AND MICROINJECTORS, ASSISTED REPRODUCTION (MQJ) (1)

Premarket Exempt

Clear

Coda® - 00815965021249 Catalog Number : C2SP-010

Device Description : Coda 2 SP incubator Unit

Device Class : 2

Duns Number: 141732011

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

LifeGlobal® Micropipet - 00815965021331 Catalog Number : MPAH-30*01*

Device Description : LG µPipets: Assisted Hatching 30° - YELLOW (single)

Device Class : 2

Duns Number: 141732011

Premarket Exempt : No

Product Code : MQJ

Prescription Use : Yes

Device Count : 1

Coda® - 00815965021348 Catalog Number : GCAF-701

Device Description : Coda Aero 700/800 Semi-Annual Filter (Single)

Device Class : 2

Duns Number: 141732011

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Coda® - 00815965021355 Catalog Number : CAFK-901

Device Description : Choice A:CodaAir 900 Semi-Annual Shirtbox Filter(Single)

Device Class : 2

Duns Number: 141732011

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Coda® - 00815965021416 Catalog Number : CCFK-900

Device Description : CodaAir 900 Annual Filter kit-4 canisters+Prefilters+HEPA

Device Class : 2

Duns Number: 141732011

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Coda® - 00815965021423 Catalog Number : CCLA-082

Device Description : Coda Canister Lo-Boy Initial/Annual kit

Device Class : 2

Duns Number: 141732011

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Coda® - 00815965021430 Catalog Number : CCLS-082

Device Description : Coda Canister Lo-Boy Semi-Annual kit

Device Class : 2

Duns Number: 141732011

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Coda® - 00815965021447 Catalog Number : CCSK-900

Device Description : CodaAir 900 Semi-Annual Filter kit..4 canisters +Prefilters

Device Class : 2

Duns Number: 141732011

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Coda® - 00815965021454 Catalog Number : CCTA-081

Device Description : Coda Canister Tower Initial/Annual kit

Device Class : 2

Duns Number: 141732011

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

Coda® - 00815965021461 Catalog Number : CCTS-081

Device Description : Coda Canister Tower Semi-Annual kit

Device Class : 2

Duns Number: 141732011

Premarket Exempt : No

Product Code : MQG

Prescription Use : Yes

Device Count : 1

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