FDA.reportPublic FDA data

Statlock IV

Primary DI
10801741082334
Brand
Statlock IV
Company
Bard Access Systems, Inc.
Model
IV0639
Catalog number
IV0639
Device description
StatLock IV Select micro 6in MaxPlus
Published
2016-09-15
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741082334PackageGS125In Commercial Distribution
20801741082331PackageGS110In Commercial Distribution
00801741082337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174108233410801741082334
2080174108233120801741082331
00801741082337008017410823378017410823370801741082337

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags#

DUNS number
044611812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801741082983StatLockS04020010S040200102025-05-02
10801741087582StatLockD05000002AD05000002A2025-05-02
10801741188852StatLockSEC2404320SEC24043202020-04-22
10801741188869StatLockSEC2404321SEC24043212020-04-22
00801741075452SecurisSEC0100SEC01002019-10-17
00801741081248StatLock068400047206840004722025-05-02
00801741081255StatLock068400049306840004932025-05-02
00801741081521STATLOCKCV0223CV02232023-11-09
00801741081552STATLOCKCV0226CV02262023-11-09
00801741081576STATLOCKCV0321CV03212023-11-09
00801741081675STATLOCKIB0200IB02002023-11-09
00801741081682STATLOCKIV0220IV02202023-11-09
00801741081750STATLOCKIV0500IV05002023-11-09
00801741081767STATLOCKIV0501IV05012023-11-09
00801741081897STATLOCKIV0528IV05282023-11-09
00801741082078STATLOCKIV0568IV05682023-11-09
00801741082085STATLOCKIV0569IV05692023-11-09
00801741082092STATLOCKIV0570IV05702023-11-09
00801741082139STATLOCKIV0577IV05772023-11-09
00801741082153STATLOCKIV0579IV05792023-11-09

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07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
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