FDA.reportPublic FDA data

Diversatek Healthcare

Primary DI
M7831350001
Brand
Diversatek Healthcare
Company
DIVERSATEK HEALTHCARE, INC.
Model
1350-00
Catalog number
1350-00
Device description
Stepped 5-in-1 Connector
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAZTubing, Noninvasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7831350001PrimaryHIBCC0
M7831350000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-558-6408sales@diversatekhc.com

Regulatory Flags#

DUNS number
030650113
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816734021286InnerVision®1465-401465-402018-09-18
00816734021293InnerVision®1465-501465-502018-09-18
00816734021217InnerVision®1450-021450-022018-09-18
00816734021224InnerVision®1450-401450-402018-09-18
00816734021231InnerVision®1450-501450-502018-09-18
00816734021248InnerVision®1450-561450-562018-09-18
00816734021255InnerVision®1455-401455-402018-09-18
00816734021262InnerVision®1455-501455-502018-09-18
00816734021279InnerVision®1455-561455-562018-09-18
00816734021309InnerVision®1465-561465-562018-09-18
00816734023518BullDog®1203-401203-402025-12-05
10816734023515BullDog®1203-401203-402025-12-05
M78312011160Diversatek Healthcare1201-1161201-1162025-11-14
00816734021682Diversatek HealthcareA86-1070A86-10702023-06-30
00816734021835Diversatek HealthcareA86-4300-10A86-4300-102023-06-30
00816734021859Diversatek HealthcareA86-5070A86-50702023-06-30
00816734022825Zvu®ZVU-3ZVU-32020-11-06
M78312011161Diversatek Healthcare1201-1161201-1162025-11-14
00816734023433Diversatek HealthcareMANO-KITMANO-KIT2025-05-16
00816734023440Diversatek HealthcareHRIM-KITHRIM-KIT2025-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196992805MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-22
10080196144310MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-08
10884389123997MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-08
14026704937360PLEUR-EVACTELEFLEX INCORPORATEDGAZ2026-05-08
16931918141206AllesetGRI Medical & Electronic Technology Co., Ltd.GAZ2025-06-20
10080196035106MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035120MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035151MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035168MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035229MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035243MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035250MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196996063MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10192253042917ArgyleCardinal Health 200, LLCGAZ2025-02-27
10192253043051ArgyleCardinal Health 200, LLCGAZ2025-02-27
14026704933119PLEUR-EVACTELEFLEX INCORPORATEDGAZ2024-11-18
08809083944803EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944810EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944827EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944834EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944841EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944858EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944865EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944872EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944889EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944896EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944902EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944919EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
08809083944926EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
20192253051909ArgyleCardinal Health 200, LLCGAZ2024-08-20