ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets

Primary DI
00810008211878
Brand
ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets
Company
MediVena, LLC
Model
5062 ONE-CARE PRESS & LOCK SBCWS 21G x 0.75’’, Lue
Catalog number
5062
Device description
ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets PRESS & LOCK, 21G x 0.75’’, Green, 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
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
K151991000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151991000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810008211878PackageGS150In Commercial Distribution
00810008211885PackageGS14In Commercial Distribution
00810008211861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810008211878008100082118788100082118780810008211878
00810008211885008100082118858100082118850810008211885
00810008211861008100082118618100082118610810008211861

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 Gauge21Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4045142586info@medivena.com

Regulatory Flags#

DUNS number
080740980
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

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