FDA.reportPublic FDA data

Custom Medical Specialties, Inc.

Primary DI
00815849021914
Brand
Custom Medical Specialties, Inc.
Company
CUSTOM ASSEMBLIES, INC.
Model
CMS-6079
Device description
Specimen Tube - 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
KDTContainer, Specimen Mailer And Storage, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDTContainer, Specimen Mailer And Storage, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815849021921PackageGS150In Commercial Distribution
00815849021914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815849021921008158490219218158490219210815849021921
00815849021914008158490219148158490219140815849021914

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive, sterileA sterile covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of diagnostic specimen (e.g., urine, faeces, sputum, mucous, tissue) for analysis and/or other investigation. This is a single-use device.

Regulatory Flags#

DUNS number
948904735
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815849020917Custom Medical Specialties, Inc.CMS-9872026-10-06
00815849022768Custom Medical Specialties, Inc.CMS-9072026-10-06
00815849022775Custom Medical Specialties, Inc.CMS-910V2026-10-06
00815849022782Custom Medical Specialties, Inc.CMS-912V2026-10-06
00815849022836Custom Medical Specialties, Inc.CMS-919VT2026-10-06
00815849025288Custom Medical Specialties, Inc.CMS-3002026-10-06
00815849025363Custom Medical Specialties, Inc.CMS-20102026-10-06
00815849025493Custom Medical Specialties, Inc.CMS-954V-62026-10-06
00815849025615Custom Medical Specialties, Inc.CMS-9092026-10-06
00815849025844Custom Medical Specialties, Inc.CMS-942V2026-10-06
00815849020160Custom Medical Specialties, Inc.CMS-5102016-11-21
00815849020177Custom Medical Specialties, Inc.CMS-5152016-11-21
00815849020108Custom Medical Specialties, Inc.CMS-16372016-11-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G669CNPTLS1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, SterileCorramedical Inc.KDT2026-04-07
10809160466940Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDT2025-05-15
0406691600599325 ml tube 90x 25Sarstedt Aktiengesellschaft & Co.KGKDT2025-01-28
04066916018412urine cup 76x 60Sarstedt Aktiengesellschaft & Co.KGKDT2025-01-14
10198459217074Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDT2024-12-22
04038917242561Tube 50ml, 114x28mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-10-16
04038917113571Tube 50ml, 115x28mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2024-10-07
04038917408561Tube 5ml, 75x13mmSarstedt Aktiengesellschaft & Co.KGKDT2024-09-23
0403891736995410ml Yellow CapSarstedt Aktiengesellschaft & Co.KGKDT2024-04-26
30193489107337MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
30193489107344MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
04038917112970Tube 15ml, 120x17mm, PSSarstedt Aktiengesellschaft & Co.KGKDT2023-11-07
04038917113007Tube 15ml, 120x17mm, PSSarstedt Aktiengesellschaft & Co.KGKDT2023-11-07
04038917565103Tube 15ml, 120x17mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2023-11-07
04038917238649Tube 25ml 90x25PP+ CapSarstedt Aktiengesellschaft & Co.KGKDT2023-01-19
04038917151528Tube 25ml 90x25PP+CapSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
04038917151573Tube 25ml 90x25PP+CapSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
04038917155144Tube 10ml, 100x16, PPSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
04038917155199Tube 10ml, 100x16mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
04038917155472Set of 4 Tube 12ml 99x16mmSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
04038917389112Tube 10ml 100x16 PP + CapSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
04038917429931Tube 10ml, 100x16mm, PPSarstedt Aktiengesellschaft & Co.KGKDT2023-01-18
18053326004534BC+™ COPAN ITALIA SPAKDT2022-12-07
38053326010966UriFreeCOPAN ITALIA SPAKDT2022-12-07
00613647005958FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KDT2022-12-07
14039943000016CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000023CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000030CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000047CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000054CRYO.SGreiner Bio - One GmbHKDT2022-12-06