FDA.reportPublic FDA data

HMG IV Administration Set

Primary DI
10850048235233
Brand
HMG IV Administration Set
Company
Hartman Medical Group LLC
Model
GCA9210
Device description
92” IV Administration Set ,10 drops/mL, Universal vented Spike, 15µm filter drip chamber Drip Chamber, Roller Clamp 1 Y-Injection Site from distal end, Rotating Male Luer lock
Published
2026-05-20
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
10850048235233PrimaryGS10
00850048235236Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004823523310850048235233
00850048235236008500482352368500482352360850048235236

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, noninvasiveA collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.

Regulatory Flags#

DUNS number
117654675
Device count
50
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
10850048235196HMG Needleless PRN connectorCV22026-07-31
10850048235264HMG IV Administration SetGCA10010NF2026-07-31
20850048235193HMG Needleless PRN connectorCV22026-07-31
10850048235202HMG IV extension sets- CIV007CIV0072026-05-20
10850048235219HMG IV extension sets- CIV015CIV0152026-05-20
10850048235226HMG IV extension sets- CIV030CIV0302026-05-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
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05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23