FDA.reportPublic FDA data

AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber

Primary DI
10704411004073
Brand
AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
D38305
Device description
"AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamberwith 6"" attached extension setNon-Pyrogenic fluid pathway. GRAVITY USE ONLY. Backcheck Valve. Two Split Septum Injection Sites. Two Needle-Free Injection Sites. One Rotating Male Luer Lock Adapter"
Published
2016-09-23
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
K101958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101958000AMSINO I.V. ADMINISTRATION AND EXTENSION SETSAmsino International, Inc.2010-09-29FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40704411004074PackageGS150In Commercial Distribution
10704411004073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4070441100407440704411004074
1070441100407310704411004073

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
825673239
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

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10704411017103AMSure ® Hydrophilic Latex Foley Catheters1AS41016HC2026-05-15
10704411017110AMSure ® Hydrophilic Latex Foley Catheters1AS41018HC2026-05-15
10704411017127AMSure ® Hydrophilic Latex Foley Catheters1AS41020HC2026-05-15
10704411017134AMSure ® Hydrophilic Latex Foley Catheters1AS41022HC2026-05-15
10704411017141AMSure ® Hydrophilic Latex Foley Catheters1AS41024HC2026-05-15
10704411017158AMSure ® Hydrophilic Latex Foley Catheters1AS42016HC2026-05-15
10704411017165AMSure ® Hydrophilic Latex Foley Catheters1AS42018HC2026-05-15
10704411017172AMSure ® Hydrophilic Latex Foley Catheters1AS42020HC2026-05-15
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10704411017196AMSure ® Hydrophilic Latex Foley Catheters1AS42024HC2026-05-15
10704411021544AMSure® Cystoscopy/Bladder Irrigation Set1ABL4002026-04-10
10704411021551AMSure® Four Lead Bladder Irrigation Set1ABL4042026-04-10
10704411018834AMSure ® SUTURE REMOVAL KIT1SRT0012026-04-03
10704411018841AMSure ® Suture Removal Kit1SRT0022026-04-03
10704411018858AMSure ® Suture Removal Kit1SRT001Z2026-04-03
40704411007464AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS35302026-04-03
40704411007471AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS10102026-04-03
40704411007488AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water1CIS10032026-04-03

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