CUSTOM ASSEMBLIES, INC.

Address:330 EAST MAIN STREET,PINE LEVEL,NC,27568,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

Set, Administration, Intravascular (FPA) (3) Tubing, Noninvasive (GAZ) (2) Drape, Surgical, Exempt (PUI) (1) Fiber, Medical, Absorbent (FRL) (1) Drape, Surgical (KKX) (1) Tube, Aspirating, Flexible, Connecting (BYY) (1) Tubing, Pressure And Accessories (BYX) (1)

Premarket Exempt

No Yes

Clear

Custom Medical Specialties, Inc. - 00815849023161 Catalog Number :

Device Description : 36" x 36" Bandbag - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849023185 Catalog Number :

Device Description : Custom Tubing Set w/ Multi-Step Connector - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849023208 Catalog Number :

Device Description : 62" Straight Injection Line - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849023239 Catalog Number :

Device Description : MPM Towel Pack (2 Per) - Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : FRL

Prescription Use : No

Device Count : 1

Custom Medical Specialties - 00815849023253 Catalog Number :

Device Description : Large Bore Infiltration Set - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

Custom Medical Specialties - 00815849023284 Catalog Number :

Device Description : 20" LS Extension Set - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849023307 Catalog Number :

Device Description : 12" Expandable Tube w/ 6mm Adapter Plug - Non-Sterile

Device Class : 1

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849023321 Catalog Number :

Device Description : 108" Transition Tubing - Non-Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Custom Medical Specialties - 00815849023345 Catalog Number :

Device Description : Film Reinforced XXL Gown - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Custom Medical Specialties, Inc. - 00815849023376 Catalog Number :

Device Description : 20' Tubing with MF LL - Sterile

Device Class : 2

Duns Number: 948904735

Premarket Exempt : Yes

Product Code : BYY

Prescription Use : No

Device Count : 1

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