FDA.reportPublic FDA data

HMG IV extension set CV300B

Primary DI
10850048235103
Brand
HMG IV extension set CV300B
Company
Hartman Medical Group LLC
Model
CV300B
Device description
5” (13cm) Micro Bore Trifurcated Extension Set Bonded Needleless Connectors
Published
2024-02-16
Public version status
New
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
K150513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150513000Imed Technology Intravascular Administration Set, Imed Technology Extension SetImed Technology, Inc.2015-05-28FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850048235103PrimaryGS10
00850048235106Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004823510310850048235103
00850048235106008500482351068500482351060850048235106

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
117654675
Device count
100
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850048235202HMG IV extension sets- CIV007CIV0072026-05-20
10850048235219HMG IV extension sets- CIV015CIV0152026-05-20
10850048235226HMG IV extension sets- CIV030CIV0302026-05-20
10850048235233HMG IV Administration SetGCA92102026-05-20
10850048235240HMG IV Administration SetGCA9210NF2026-05-20
10850048235257HMG IV Administration SetGCA35102026-05-20
20850048235209HMG IV extension sets- CIV007CIV0072026-05-20
20850048235216HMG IV extension sets- CIV015CIV0152026-05-20
20850048235223HMG IV extension sets- CIV030CIV0302026-05-20
10850048235172HMG Pump Driven IV Administration SetPCA10012026-05-19
10850048235189HMG Pump Driven IV Administration SetPCA10022026-05-19
40850048235098HMG IV extension set CV200BCV200B2025-10-30
50850048235088HMG IV extension Sets CV100RCV100R2025-10-30
70850048235068HMG IV Extension Set CV100BCV100B2025-10-30
70850048235075HMG IV extension sets- CVM100BCVM100B2025-10-30
80850048235072HMG IV extension sets- CVM100BCVM100B2025-10-30
10850048235158HMG Spinal NeedleSPN20G35QNSSPN20G35QNS2025-08-25
20850048235155HMG Spinal NeedleSPN20G35QNSSPN20G35QNS2025-08-25
00850048235151HMG Spinal NeedleSPN20G35QNSSPN20G35QNS2025-08-25
10850048235134HMG IV Administration SetFCA10012025-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08498840010266Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840010372Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840010389Churchill Medical SystemsVygon 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