FDA.reportPublic FDA data

AMSafe® I.V. Administration Set 106”

Primary DI
10704411010890
Brand
AMSafe® I.V. Administration Set 106”
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
FP106FY2
Device description
AMSafe® I.V. Administration Set 106” For use with Spectrum, Flo-Gard 6201 and 6301 series pumps 106” (2.6m), 10 drops/mL, Slide and Roller Clamp, Backcheck Valve, 0.22 Micron Filter, (2) Sure-Lok Needle-Free valves, Rotating Male Luer Lock with Retractable Collar, Approx. Priming Volume: 22mL
Published
2019-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40704411010891PackageGS150In Commercial Distribution
10704411010890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4070441101089140704411010891
1070441101089010704411010890

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration setA collection of noninvasive devices designed 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, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825673239
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
40704411021088AMSafe® I.V. Administration Set11010802B2025-12-29
40704411020241AMSure® 0.9% Sodium Chloride lrrigation USP 100 mL, Sterile1AS-62402025-12-05
40704411020258AMSure® Sterile Water for lrrigation USP 100 mL1AS-62502025-12-05
00704411020267AMSure® Sterile Water for lrrigation USP 250 mL1AS-62602025-12-05
40704411020272AMSure® 0.9% Sodium Chloride lrrigation USP 250 mL, Sterile1AS-62702025-12-05
40704411020500AMSure® 0.9% Sodium Chloride lrrigation USP 500 mL, Sterile1AS-63802025-12-05
40704411020517AMSure® Sterile Water for lrrigation USP 500 mL1AS-63902025-12-05
40704411020524AMSure® 0.9% Sodium Chloride lrrigation USP 1000 mL, Sterile1AS-64812025-12-05
40704411020531AMSure® Sterile Water for lrrigation USP 1000 mL1AS-64912025-12-05
40704411008829AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716102025-07-02
40704411008836AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716122025-07-02
40704411008843AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716142025-07-02
40704411008850AMSure ® HG Hydrophilic Intermittent Urethral Catheter1HG9716162025-07-02
10704411008866AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971610SS2025-07-02
40704411008874AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971612SS2025-07-02
40704411008881AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971614SS2025-07-02
40704411008898AMSure®HG Hydrophilic Intermittent Urethral Catheter1HG971616SS2025-07-02
40704411019542AMSure® Foley Catheter Tray1AS894142025-07-01
40704411019559AMSure® Foley Catheter Tray1AS894162025-07-01
40704411019566AMSure® Foley Catheter Tray1AS894182025-07-01

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00813153028155FRESENIUS KABICodan US CorporationFPA2026-02-05
B2125720502Male Luer Slip PlugINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700B2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700G2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700R2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700V2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700W2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700Y2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
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