FDA.reportPublic FDA data

Custom Medical Specialties, Inc.

Primary DI
00815849021815
Brand
Custom Medical Specialties, Inc.
Company
CUSTOM ASSEMBLIES, INC.
Model
CMS-6025
Device description
Absorbent Pad - Sterile
Published
2016-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRLFiber, Medical, Absorbent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815849021822PackageGS125In Commercial Distribution
00815849021815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815849021822008158490218228158490218220815849021822
00815849021815008158490218158158490218150815849021815

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent underpad, sterileA sterile flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures or incontinence. It is intended to be used in the healthcare facility and in the home. This is a single-use device.

Regulatory Flags#

DUNS number
948904735
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815849020108Custom Medical Specialties, Inc.CMS-16372016-11-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536925007BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925014BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925021BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925038BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925045BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925052BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925069BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925076BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925083BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925090BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925106BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925113BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925120BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925137BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925144BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925151BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925168BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
20197344219428MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219442MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219459MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219466MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219473MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219480MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219497MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219503MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219435MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-13
10814707025023CygnusASPEN SURGICAL PRODUCTS, INC.FRL2026-04-10
10850018327982MHMazza Healthcare LLCFRL2026-04-09
B090MT630MorTanZien Medical Technologies, LLCFRL2026-02-17
00858303003002SynterventionZien Medical Technologies, LLCFRL2025-09-25