Encompass Group, L.L.C.

Address:615 MACON RD.,Mc Donough,GA,30253,US

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Filters

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

Fiber, Medical, Absorbent (FRL) (4) Gown, Examination (FME) (3) System, Thermal Regulating (DWJ) (2) Drape, Surgical, Exempt (PUI) (1)

Premarket Exempt

No Yes

Clear

Nova - 00612899006485 Catalog Number :

Device Description : NOVA BLANKET, UPPER BODY NOVA BLANKET, UPPER BODY,70 NOVA BLANKET, UPPER BODY NOVA BLANKET, UPPER BODY,70"W X 25"L,IND PKG,25 EA/CS

Device Class : 2

Duns Number: 121788819

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Nova - 00612899006492 Catalog Number :

Device Description : Nova Blanket, Lower BodyNova Blanket, Lower Body, 30"W x 51"L, IND PKG, 25 EA/CS

Device Class :

Duns Number: 121788819

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

COVAIRE - 00612899239685 Catalog Number : 7389-CLDR

Device Description : COVAIRE BARRIER DRAPEAEROSOL CONTAINMENT DRAPE, CLEAR, UNIV 100/CS

Device Class : 2

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

Encompass - 10612899000091 Catalog Number :

Device Description : TECHSTYLES TOWEL, 14X19, 350EA TS TOWEL, BLUE, DRC, 350 BULK NONWOVEN

Device Class :

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 350

Encompass - 10612899000251 Catalog Number :

Device Description : PATIENT CLEANER 12X13.5 2000EA TS PATIENT CLNR, BUL PATIENT CLEANER 12X13.5 2000EA TS PATIENT CLNR, BULK, WHITE, RAYON/POLY, 250/BG, 8 BG/CS NW

Device Class :

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 2000

Encompass - 10612899000374 Catalog Number :

Device Description : INFANT SHIRT, NB, 300EA TS INFANT SHIRT, SHORT INFANT SHIRT, NB, 300EA TS INFANT SHIRT, SHORT SLV, PRINT, PET, 25/BG, 12 BG/CS NW

Device Class :

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : FME

Prescription Use : Yes

Device Count : 300

Encompass - 10612899000381 Catalog Number :

Device Description : INFANT SHIRT, NB, 300EA TS INFANT SHIRT, LONG S INFANT SHIRT, NB, 300EA TS INFANT SHIRT, LONG SLV, PRINT, PET, 25/BG, 12 BG/CS NW

Device Class :

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : FME

Prescription Use : Yes

Device Count : 300

Encompass - 10612899000404 Catalog Number :

Device Description : TECHSTYLES TOWEL, 18X38, 200EA TS TOWEL, BLUE, DRC, 200 BULK NONWOVEN

Device Class :

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 200

Encompass - 10612899000510 Catalog Number :

Device Description : WASHCLOTH, 12X13, 1000EA TS WASHCLOTH, WHITE, DRC, 50/B WASHCLOTH, 12X13, 1000EA TS WASHCLOTH, WHITE, DRC, 50/BG, 20 BG/CS NONWOVEN

Device Class :

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : Yes

Device Count : 1000

Encompass - 10612899001531 Catalog Number :

Device Description : PATIENT ROBE, S-M, 25EA TS PATIENT ROBE, DARK BLUE, SB PATIENT ROBE, S-M, 25EA TS PATIENT ROBE, DARK BLUE, SBPP, 25 BULK NONWOVEN

Device Class :

Duns Number: 121788819

Premarket Exempt : Yes

Product Code : FME

Prescription Use : Yes

Device Count : 25

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