FDA.reportPublic FDA data

Q2 IV Administration Set

Primary DI
00634624101258
Brand
Q2 IV Administration Set
Company
QUEST MEDICAL INC
Model
ASV10125
Published
2022-12-06
Public version status
Update
Distribution status
Not 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
K213588000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213588000Q2 IV Administration SetsQuest Medical, Inc.2022-06-02FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20634624101252PackageGS150Not in Commercial Distribution
00634624101258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2063462410125220634624101252
00634624101258006346241012586346241012580634624101258

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.

Regulatory Flags#

DUNS number
041810693
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
true
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
00634624530485MPS® 3 Console Pole Mount Plate530102453010242026-07-20
006346240906516" (15 cm) Microbore Extension Set with Clamp90652017-02-13
006346240925017 in (18cm) Y-Extension Set w/ 2 check valves925092502016-07-26
0063462409541044 in (112 cm) Q2 CheckMate Extension Set with inline checkvalve and Q2 Y-site954195412016-07-26
00634624095434Q2 Checkmate Extension Set95432016-06-10
00634624101159Q2 IV Administration SetASV101152022-12-06
00634624101302Q2 IV Administration SetASV101302022-12-06
00634624601253Q2 IV Administration SetASV601252022-12-06
00634624621015Precision Delivery IV Extension SetPD602021-02-05
00634624621022Precision Delivery IV Extension SetPD60F2021-02-05
00634624621039Precision Delivery IV Extension SetPDM602021-02-05
00634624621046Precision Delivery IV Extension SetPDM60F2021-02-05
00634624621053Precision Delivery IV Extension SetPDMV602021-02-05
00634624621060Precision Delivery IV Extension SetPDMV60F2021-02-05
00634624621077Precision Delivery IV Extension SetPDV062021-02-05
00634624621084Precision Delivery IV Extension SetPDV06F2021-02-05
00634624621091Precision Delivery IV Extension SetPDV602021-02-05
00634624621107Precision Delivery IV Extension SetPDV60F2021-02-05
00634624621114Precision Delivery Trifurcated IV Extension SetPDT052021-02-05
00634624621121Precision Delivery Trifurcated IV Extension SetPDT05DF2021-02-05

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