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 Companion, Blue-LANG C - 10857808005112 Catalog Number : 100-0013-LANG C

Device Description : Companion, Blue-LANG C

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Companion, Magenta-LANG A - 10857808005129 Catalog Number : 100-0014-LANG A

Device Description : Companion, Magenta-LANG A

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Companion, Magenta-LANG B - 10857808005136 Catalog Number : 100-0014-LANG B

Device Description : Companion, Magenta-LANG B

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Companion, Magenta-LANG C - 10857808005143 Catalog Number : 100-0014-LANG C

Device Description : Companion, Magenta-LANG C

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Tubing Set - 10857808005150 Catalog Number : 100-0016

Device Description : Tubing Set

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Starter Kit, Blue-LANG A - 10857808005167 Catalog Number : 100-0017-LANG A

Device Description : Starter Kit, Blue-LANG A

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Starter Kit, Blue-LANG B - 10857808005174 Catalog Number : 100-0017-LANG B

Device Description : Starter Kit, Blue-LANG B

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Starter Kit, Blue-LANG C - 10857808005181 Catalog Number : 100-0017-LANG C

Device Description : Starter Kit, Blue-LANG C

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Starter Kit, Magenta-LANG A - 10857808005198 Catalog Number : 100-0018-LANG A

Device Description : Starter Kit, Magenta-LANG A

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

AspireAssist Starter Kit, Magenta-LANG B - 10857808005204 Catalog Number : 100-0018-LANG B

Device Description : Starter Kit, Magenta-LANG B

Device Class : 3

Duns Number: 026281163

Premarket Exempt : No

Product Code : OYF

Prescription Use : Yes

Device Count : 1

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