FDA.reportPublic FDA data

Q2 Vial Adapter, 20 mm

Primary DI
20634624031603
Brand
Q2 Vial Adapter, 20 mm
Company
QUEST MEDICAL INC
Model
3160
Catalog number
3160
Device description
The Q2 Vial Adapter allows for multiple needleless access to injection medication vials for transfer or withdrawl of fluids form the vial.
Published
2016-07-14
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

Contact Domains#

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
K040634000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040634000ROBERTSITE VIAL ADAPTER, MODEL 245700021Halkey-Roberts Corp.2004-03-23LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20634624031603PrimaryGS10
00634624031609Unit of UseGS10
90634624031602Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2063462403160320634624031603
00634624031609006346240316096346240316090634624031609
9063462403160290634624031602

GMDN Terms#

Term, Definition table
TermDefinition
Vial/bottle adaptor, non-hermeticA device intended to be fitted to a vial or bottle to enable the removal of its contents, (e.g., medication, nutritional solution for enteral feeding) into a syringe, for subsequent administration to a patient. It is typically a housing with a syringe connector that attaches to the container or replaces its lid; it does not allow for pressure equalization/airtight transfer of contents. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-627-0226Custserv@questmedical.com

Regulatory Flags#

DUNS number
041810693
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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00634624921207Q2 Blood Administration SetYV1152022-12-06
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