FDA.reportPublic FDA data

Q2 Checkmate Extension Set

Primary DI
20634624095438
Brand
Q2 Checkmate Extension Set
Company
QUEST MEDICAL INC
Model
9543
Device description
44 inch (122 cm) with 3 pressure activated checkvalves, inline checkvalve, detachable. Approximate priming volume 6.4mL.
Published
2016-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K800825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K800825000EXTENSION SET QUEST CODE #3000Quest Medical, Inc.1980-05-14FPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20634624095438PackageGS150In Commercial Distribution
00634624095434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2063462409543820634624095438
00634624095434006346240954346346240954340634624095434

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

Contacts#

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

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
false
Sterilization required before use
false

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