FDA.report

Wilburn Medical USA

Primary DI
00628725004440
Brand
Wilburn Medical USA
Company
Canadian Hospital Specialties Limited
Model
WUSA/0403
Catalog number
WUSA/0403
Device description
4" MINIBORE, NON-DEHP, T-PORT SET
Published
2017-04-11
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

Related Records

Product Codes

CodeName
FPASet, Administration, Intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50628725004445PackageGS1100In Commercial Distribution
00628725004440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872500444550628725004445
00628725004440006287250044406287250044400628725004440

GMDN Terms

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

Regulatory Flags

DUNS number
240992693
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
false
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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