ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets

Primary DI
00810008211892
Brand
ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets
Company
MediVena, LLC
Model
5061 ONE-CARE PRESS & LOCK SBCWS 23G x 0.75’’, Lue
Catalog number
5061
Device description
ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets PRESS & LOCK, 23G x 0.75’’, Blue, Luer Adapter, 12'' Tube, 50/bx, 4bx/cs
Published
2024-09-27
Public version status
New
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
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151991000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151991000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810008211908PackageGS150In Commercial Distribution
00810008211915PackageGS14In Commercial Distribution
00810008211892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810008211908008100082119088100082119080810008211908
00810008211915008100082119158100082119150810008211915
00810008211892008100082118928100082118920810008211892

GMDN Terms#

Term, Definition table
TermDefinition
Basic intravenous administration set, invasiveA collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.75Inch
Needle Gauge23Gauge

Contacts#

Phone, Email table
PhoneEmail
4045142586info@medivena.com

Regulatory Flags#

DUNS number
080740980
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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