FDA.reportPublic FDA data

IV Extension Set

Primary DI
00616784706030
Brand
IV Extension Set
Company
DYNAREX CORPORATION
Model
7060
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012189000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012189000ANGELTOUCH VENTED IV ADMINISTRATION SETAngiplast Private , Ltd.2002-03-05LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784706030PackageGS14In Commercial Distribution
00616784706023PrimaryGS10
00616784706016Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784706030006167847060306167847060300616784706030
00616784706023006167847060236167847060230616784706023
00616784706016006167847060166167847060160616784706016

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
100
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00840117338135Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve363942024-07-25
00840117326156Resp-O2 M9 Oxygen C-Cylinder 1.7L363922023-12-29
00840117327511Resp-O2 M6 Oxygen B-Cylinder,1L With CGA870 Post Valve363932023-12-29
00840117327528Resp-O2 M15 Oxygen D-Cylinder, 2.9 L With CGA 870 Post Valve363912023-12-29
00840117326125Resp-O2 M24 Oxygen E-Cylinder, With CGA870 Post Valve363902023-03-24
00840117310162Resp-O2 Fingertip Pulse Oximeter, For Adult Use364002021-12-22
00840117341241Aluminum Crutches, Child, 4'0" - 4'6"10100-82026-07-31
00840117341258Aluminum Crutches, Youth, 4'6" - 5'2"10101-82026-07-31
00840117341265Aluminum Crutches, Adult, 5'2" - 5'10"10102-82026-07-31
00840117341272Aluminum Crutches, Tall, 5'10" - 6'6"10103-82026-07-31
00840117341357Forearm Crutches, Youth, 4'2" - 5'2"10110-62026-07-31
00840117341364Forearm Crutches, Adult, 5'0" - 6'2"10111-62026-07-31
00840117341371Forearm Crutches, Tall, 5'10" - 6'6"10112-62026-07-31
00840117346253Pill Crusher Pouches with Round Corners4210R2026-07-31
00840117349551Drape Sheets, Polypropylene/Polyethylene 2-ply, Black, 40" x 90" (101.6 cm x 22881562026-07-31
00840117350069Pillow Cases, Polypropylene/Polyethylene 2-ply, Black, 21" x 30"81672026-07-31
00840117351684Universal Catheterization Procedure Trays with 2000 mL Anti-Reflux Drainage Bag50032026-07-31
00840117351875Resp-O2 Single Suction Catheters, Pediatric Graduated Catheter32000S2026-07-31

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