FDA.reportPublic FDA data

WOLF-PACK / BIOSITE / BIOSITE PLUS

Primary DI
00810083350820
Brand
WOLF-PACK / BIOSITE / BIOSITE PLUS
Company
Sensimedical LLC
Model
BI8500
Catalog number
BI8500
Device description
BI8500 300 psi Opaque Needleless Neutral Valve
Published
2024-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121511000MACLIN POWER INTRAVASCULAR ADMINISTRATION SETMaclin Power, Inc.2013-03-07FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810083350363PackageGS11000In Commercial Distribution
00810083350370PackageGS1100In Commercial Distribution
00810083350820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810083350363008100833503638100833503630810083350363
00810083350370008100833503708100833503700810083350370
00810083350820008100833508208100833508200810083350820

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Regulatory Flags#

DUNS number
117526048
Device count
1
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
00810083350608SENSIMEDICAL Sterile Water, USP787180004778718000472025-10-09
00810083350622SENSIMEDICAL Sterile Water, USP787180004878718000482025-10-09
00810083350646SENSIMEDICAL Sterile Water, USP787180004978718000492025-10-09
00810083350660SENSIMEDICAL Sterile Water, USP787180005078718000502025-10-09
00810083350707SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180005278718000522025-10-09
00810083350721SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180005378718000532025-10-09
00810083350745SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180005478718000542025-10-09
00810083350769SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180005578718000552025-10-09
00810083351124SENSIMEDICAL Sterile Water, USP787180006278718000622025-10-09
00810083351148SENSIMEDICAL Sterile Water, USP787180006378718000632025-10-09
00810083351186SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180006578718000652025-10-09
00810083351209SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180006678718000662025-10-09
00810083351223SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180006778718000672025-10-09
00810083351247SENSIMEDICAL Sterile 0.9% Normal Saline, USP787180006878718000682025-10-09
00810083350561SENSIMEDICAL Sterile Water for Inhalation, USP787180004578718000452025-10-06
00810083350585SENSIMEDICAL Sterile Water for Inhalation, USP787180004678718000462025-10-06
00810083351087SENSIMEDICAL Sterile Water, USP787180006078718000602025-10-06
00810083351100SENSIMEDICAL Sterile Water, USP787180006178718000612025-10-06
00810083350462BIOSITE/BIOSITE PLUSJR-017-AUJR-017-AU2024-05-28
00810083350523BIOSITE/BIOSITE PLUSJR-044-AUJR-044-AU2024-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840009338VYGONVygon CorporationFPA2020-04-21
08498840009895VYGONVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30