AMSafe® Microbore Extension Set

Primary DI
40704411012185
Brand
AMSafe® Microbore Extension Set
Company
AMSINO INTERNATIONAL, INC.
Model
1
Catalog number
IVE2501
Device description
AMSafe® Microbore Extension Set 100 inch long (254cm) CAUTION: Avoid freezing and excessive heat.
Published
2020-04-17
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093773000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093773000AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETSAmsino International, Inc.2010-03-10FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40704411012185PackageGS11In Commercial Distribution
10704411012184PrimaryGS10
00704411012187Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4070441101218540704411012185
1070441101218410704411012184
00704411012187007044110121877044110121870704411012187

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
50
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

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