FDA.reportPublic FDA data

Custom Medical Specialties, Inc.

Primary DI
00815849022478
Brand
Custom Medical Specialties, Inc.
Company
CUSTOM ASSEMBLIES, INC.
Model
CMS-943
Device description
Collection Bag Y-Connector - Non-Sterile
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NVTTubing And Tubing/Filter Fits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVTTubing And Tubing/Filter FitsObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815849022478PackageGS110In Commercial Distribution
00815849022461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815849022478008158490224788158490224780815849022478
00815849022461008158490224618158490224610815849022461

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain connectorA tubular, noninvasive device designed to connect compatible components of a closed-wound drainage kit (e.g., the drain tubing to the drain bag or reservoir); it is not intended to connect components of suction systems (e.g., not used in general surgery). It will typically be shaped as a straight bore connector or a Y-piece connector. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
948904735
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815849020160Custom Medical Specialties, Inc.CMS-5102016-11-21
00815849020177Custom Medical Specialties, Inc.CMS-5152016-11-21
00815849021556Custom Medical Specialties, Inc.CMS-1637-NS2016-11-21
00815849021839Custom Medical Specialties, Inc.CMS-5862016-11-21
00815849024021Custom Medical Specialties, Inc. CMS-2732-R42023-09-14
00815849024571Custom Medical Specialties, Inc. CMS-6314-R62023-09-14
00815849023369Custom Medical Specialties, Inc. CMS-12352023-09-13
00815849023390Custom Medical Specialties, Inc. CMS-12382023-09-13
00815849023406PG-1000PG-10002023-09-13
00815849023437Custom Assemblies, Inc. CMS-2012-R32023-09-13
00815849023444Custom Assemblies, Inc. CMS-8322-R12023-09-13
00815849023451Custom Medical Specialties, Inc. CMS-5650-R22023-09-13
00815849023468Custom Medical Specialties, Inc. CMS-63822023-09-13
00815849023475Custom Medical Specialties, Inc. CMS-6439-C2023-09-13
00815849023482MPMMPM-312-R12023-09-13
00815849023499Custom Medical Specialties, Inc. CMS-1911-R32023-09-13
00815849023505MPMMPM-2952023-09-13
00815849023512Custom Medical Specialties, Inc. CMS-2450-R42023-09-13
00815849023529Custom Medical Specialties, Inc. CMS-4439-R52023-09-13
00815849023536Custom Medical Specialties, Inc. CMS-6803-R12023-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327626469ThermaClearSTRYKER CORPORATIONNVT2025-04-04
05055270979636RocketROCKET MEDICAL PLCNVT2023-10-24
05055270979667RocketROCKET MEDICAL PLCNVT2023-10-24
05055270986504RocketROCKET MEDICAL PLCNVT2023-10-24
05055270979643RocketROCKET MEDICAL PLCNVT2023-10-24
05055270979674RocketROCKET MEDICAL PLCNVT2023-10-24
05055270986511RocketROCKET MEDICAL PLCNVT2023-10-24
05708265011179LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
05708265011841LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
05708265011186LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
05708265011858LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2020-08-03
04048438003497n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438003619n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438004401n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438004692n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438001080n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438000762n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438000823n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
04048438006306n.a.Karl Storz GmbH & Co. KGNVT2019-02-23
05708265010585LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2018-04-11
05708265010592LiNA OperaScope™ Tubing & Drape kitLina Medical ApSNVT2018-04-11
00815849020191Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020207Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020214Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849022461Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020764Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020771Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09
00815849020788Custom Medical Specialties, Inc.CUSTOM ASSEMBLIES, INC.NVT2016-12-09