ASPIRE BARIATRICS, INC.

Address:319 N. Pottstown Pike Suite 202,Exton,PA,19341,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

Aspiration Therapy System (OYF) (10)

Premarket Exempt

Clear

AspireAssist Starter Kit, Magenta-LANG C - 10857808005211 Catalog Number : 100-0018-LANG C

Device Description : Starter Kit, Magenta-LANG C

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

Foam Swab 20 Pack - 10857808005228 Catalog Number : 100-0019

Device Description : Foam Swab 20 Pack

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Lanyard - 10857808005235 Catalog Number : 100-0020

Device Description : Lanyard

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Carry Bag - 10857808005242 Catalog Number : 100-0021

Device Description : Carry Bag

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : No

Device Count : 1

AspireAssist Emergency Clamp - 10857808005259 Catalog Number : 100-0029

Device Description : Emergency Clamp

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Skin-Port-LANG A - 10857808005266 Catalog Number : 200-0011-LANG A

Device Description : Skin-Port-LANG A

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Skin-Port-LANG B - 10857808005273 Catalog Number : 200-0011-LANG B

Device Description : Skin-Port-LANG B

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Skin-Port-LANG C - 10857808005280 Catalog Number : 200-0011-LANG C

Device Description : Skin-Port-LANG C

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Skin-Port Sleeve, Multipack (5x)-LANG A - 10857808005297 Catalog Number : 100-0007-LANG A

Device Description : Skin-Port Sleeve, Multipack (5x)-LANG A

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Skin-Port Sleeve, Multipack (5x)-LANG B - 10857808005303 Catalog Number : 100-0007-LANG B

Device Description : Skin-Port Sleeve, Multipack (5x)-LANG B

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

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