FDA.reportPublic FDA data

MEDADV

Primary DI
00819667020166
Brand
MEDADV
Company
MEDAS INC
Model
M101
Catalog number
M101
Device description
"INTRAVENOUS FLUID ADMINISTRATION SET 150 CM, VENTED, FILTER, Y SITE, NEEDLE 21G X 1 1/2 """
Published
2018-04-12
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

Contact Domains#

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
K083687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083687000BAIXIN INTRAVASCULAR ADMINISTRATION SETAnhui Kangda Medical Products Co., Ltd.2009-06-11FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10819667020163PackageGS120In Commercial Distribution
00819667020166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081966702016310819667020163
00819667020166008196670201668196670201660819667020166

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(786)832-0459customerservice@medasusa.com

Regulatory Flags#

DUNS number
080593067
Device count
1
Lot or batch
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
00819667020746MEDADVM95F61135JM95F61135J2018-04-09
00819667020753MEDADVM95R50721SM95R0721S2018-04-09
00819667020784MEDADVM962P0SM962P0S2018-04-11
00819667020791MEDADVM962P20XLM962P20XL2018-04-11
00819667020807MEDADVM962P20M962P202018-04-11
00819667020814MEDADVM962P20LM962P20L2018-04-11
00819667020647MEDADVM93135150AM93135150A2018-04-11
00819667020654MEDADVM93135260AM93135260A2018-04-09
00819667020982MEDADVM507M5072018-04-11
00819667020258MEDADVM209M2092018-04-10
00819667020265MEDADVM206M2062018-04-11
00819667020272MEDADVM207M2072018-04-10
00819667020289MEDADVM210M2102018-04-09
10819667020064MEDADVM711M7112018-03-01
10819667020071MEDADVM712M7122018-03-01
10819667020088MEDADVM713M7132018-03-01
10819667020095MEDADVM714M7142018-03-01
10819667020101MEDADVM716M7162018-03-01
10819667020118MEDADVM717M7172018-03-01
00819667020043MEDADVM705M7052018-01-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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