FDA.report

IV3000 FRAME 6CMX7CM CE CTN OF 100

Primary DI
00040565120591
Brand
IV3000 FRAME 6CMX7CM CE CTN OF 100
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
59410082
Catalog number
59410082
Device description
Moisture responsive IV catheter dressing
Published
2020-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00040565120591PackageGS1100In Commercial Distribution
30040565120592PackageGS110In Commercial Distribution
00040565120584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00040565120591000405651205910405651205910040565120591
3004056512059230040565120592
00040565120584000405651205840405651205840040565120584

GMDN Terms

TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
216344051
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

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05000223501709ALLEVYN™ Ag+66027665660276652025-08-12
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