CUSTOM ASSEMBLIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1063382	3000718854	CUSTOM ASSEMBLIES, INC.	1	N	2026-01-01	330 EAST MAIN STREET PINE LEVEL NC US 27568

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
16498	1193033429	K993463	INTRAVASCULAR ADMINISTRATION SET	FPA	2000-01-04
16498	1641026977	K912861	FLU ADMIN/WASTE DISP SYS/PROTEC STA/ADMIN/FLUSH-N-	FPA	1991-09-24
16498	1005031441
16498	1158179783
16498	1197783263
16498	1239068718
16498	1272780025
16498	1323461145
16498	1368263865
16498	1398652981
16498	1399537269
16498	1424680424
16498	1451061729
16498	1612239714
16498	1683145399
16498	1723168320
16498	1763419476
16498	1789985119
16498	1843066513
16498	1884586153
16498	1056207802
16498	1074464890
16498	1107945760
16498	1175098894
16498	1192942344
16498	1225982294
16498	1441562375
16498	1802959627
16498	1952895728
16498	1954820968
16498	1979378319
16498	2072773663

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FPA	3	2000-01-04

PMN#

INTRAVASCULAR ADMINISTRATION SET
2000-01-04
CUSTOM ASSEMBLIES, INC.

GUDID#

Custom Medical Specialties, Inc. - Needle Holder - Sterile
CUSTOM ASSEMBLIES, INC.
2016-11-21
Custom Medical Specialties, Inc. - 15L Collection Container - Non-Sterile
CUSTOM ASSEMBLIES, INC.
2016-11-21
Custom Medical Specialties, Inc. - 15L Collection Container w/ Absorbent Powder - Non-Sterile
CUSTOM ASSEMBLIES, INC.
2016-11-21
Custom Medical Specialties, Inc. - Sharps Collection System - Non-Sterile
CUSTOM ASSEMBLIES, INC.
2016-11-21
Custom Medical Specialties, Inc. - 15L Tissue Trap Collection Bag w/ Absorbent Powder - Non-Sterile
CUSTOM ASSEMBLIES, INC.
2016-11-21
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-14
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-14
Custom Medical Specialties, Inc. - 8’ Extension Set with Check Valve
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - "144"" Transition Tubing"
CUSTOM ASSEMBLIES, INC.
2023-09-13
PG-1000 - Puregraft Smart Tubing
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Assemblies, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Assemblies, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
MPM - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
MPM - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13
Custom Medical Specialties, Inc. - Procedure Kit
CUSTOM ASSEMBLIES, INC.
2023-09-13

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