FDA.reportPublic FDA data

Q2 Blood Administration Set

Primary DI
20634624921201
Brand
Q2 Blood Administration Set
Company
QUEST MEDICAL INC
Model
YV115
Published
2022-12-06
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
K213846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213846000Q2 Blood Administration SetsQuest Medical, Inc.2022-06-05FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20634624921201PackageGS150In Commercial Distribution
00634624921207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2063462492120120634624921201
00634624921207006346249212076346249212070634624921207

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion set, non-exchangeAn intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.

Sterilization Methods#

Method table
Method

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
20634624530380MPS 3 Medical Air Hose Kit5303010-CA2023-10-16
10634624100616Tie-V Securement DeviceQIVB00602022-12-15
00634624417021Lyka® PORT Needle Free Access Device4170Y2025-06-12
20634624533039Vessel Cannula, 3mmVCC-03VCC-032016-06-07
00634624031500Q2® Needleless injection site 315031502017-03-09
20634624100606Qlinch Securement BandQSB00602020-04-08
00634624096523Checkmate IV Administration Set 123in (312 cm)965296522016-07-29
20634624530397MPS 3 Drug Pump Cover53030312023-03-24
00634624911109Precision Delivery Bifurcated IV Extension SetPDBV05F2022-12-19
00634624911048High-Flow Extension SetHF01352022-12-12
00634624101159Q2 IV Administration SetASV101152022-12-06
00634624101258Q2 IV Administration SetASV101252022-12-06
00634624101302Q2 IV Administration SetASV101302022-12-06
00634624601253Q2 IV Administration SetASV601252022-12-06
00634624921092High-Flow 4-Way StopcockSTV022022-12-06
00634624921108High-Flow 4-Way StopcockSTV032022-12-06
00634624921160High-Flow 4-Way StopcockST012022-12-06
00634624921191High-Flow 4-Way StopcockST032022-12-06
00634624921207Q2 Blood Administration SetYV1152022-12-06
00634624921214Q2 Blood Administration SetYV1302022-12-06

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04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
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