FDA.report

Custom Medical Specialties, Inc.

Primary DI
00815849020641
Brand
Custom Medical Specialties, Inc.
Company
CUSTOM ASSEMBLIES, INC.
Model
CMS-1222
Device description
Fluid Control System - Non-Sterile
Published
2016-12-07
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

Related Records

Product Codes

CodeName
BYYTube, Aspirating, Flexible, Connecting

Product Code Classifications

CodeDeviceSpecialtyClass
BYYTube, Aspirating, Flexible, ConnectingGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815849020641PackageGS1100In Commercial Distribution
00815849020061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815849020641008158490206418158490206410815849020641
00815849020061008158490200618158490200610815849020061

GMDN Terms

TermDefinition
Vacuum tubing, single-useA sterile, flexible, cylindrical device used as a connection line between a vacuum source and a medical device, medical equipment, or a medical system that is dependent upon suction to operate or function. It is typically made of a malleable plastic or silicone material and is designed with a thick wall to prevent collapse due to the negative pressure of the vacuum; it is available in a variety of lengths, including standard coil lengths. This device is used when sterile conditions are required, e.g., for an autologous blood transfusion system. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

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
true
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00815849023543Custom Medical Specialties, Inc. CMS-8963-R12023-09-13
00815849023550Custom Medical Specialties, Inc. CMS-6415-R12023-09-13
00815849023567Custom Medical Specialties, Inc. CMS-8522-R22023-09-13
00815849023574Custom Medical Specialties, Inc. CMS-4028-R52023-09-13

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