STATLOCK CV0321

GUDID 20801741081570

SL CV ULTRA DUAL PT TETHERED LOCKNG CAPS

Bard Access Systems, Inc.

Wearable percutaneous catheter/tube holder

• Primary Device ID: 20801741081570
• NIH Device Record Key: baaed2f5-5b7e-401f-93a1-a752f8bcf407
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STATLOCK
• Version Model Number: CV0321
• Catalog Number: CV0321
• Company DUNS: 044611812
• Company Name: Bard Access Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741081576 [Primary]
GS1	10801741081573 [Package]; Contains: 00801741081576; Package: Shelfpack [25 Units]; In Commercial Distribution
GS1	20801741081570 [Package]; Contains: 10801741081573; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• KMK: DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-17
• Device Publish Date: 2023-11-09

On-Brand Devices [STATLOCK]

• 20801741188866: Dressing, Securis Non-Sterile
• 20801741188859: Base, Securis Non-Sterile
• 10801741082464: DOT SL IVULT KIT FREPP
• 10801741082426: DOT SL IVPREM KIT SEPP OPTION LOK
• 10801741082419: DOT SL IVPREM KIT MACRO EXT SEPP
• 10801741096379: DOT SL IVPREM KIT MACRO RETR SEPP BAXTER
• 10801741082655: DOT SL IVNEXIVA KIT SEPP
• 10801741082518: DOT SL IV PREM KIT FREPP OPTION LOK
• 10801741083393: SL PICC PLUS CRESC FOAM FIXED POST CE
• 20801741083345: SL PICC PLUS BTFLY FIXED POST
• 10801741082389: DOT SL IVULT KIT PED SEPP
• 10801741083553: SL PICC PLUS FIXED POST CRESC
• 10801741083539: SL DIAL II MEDCOMP BULK
• 10801741083461: SL UNIV PLUS LRG 14-16FR W/SKIN PREP
• 10801741083355: SL PICC PLUS BTFLY SLIDING POST
• 20801741083291: SL IV INTIMA PLUS
• 10801741083256: SL DIAL ARROW HEMO CLAMP
• 20801741083246: SL PICC BD FIRST PICC FIXED PT TAILHOOK
• 10801741083171: SL DIAL II DUAL RETAINER
• 10801741083140: SL CV W/PIGTAIL
• 10801741083126: SL CV PLUS FOAM W/PIGTL CRESC SLIDING PT
• 20801741083116: SL CV PLUS W/PIGTAIL BTFLY SLIDING POST
• 20801741083086: SL PICC II FIXED POST CLAMP
• 20801741083031: SL ART PAD FOR ARROW
• 10801741082907: SL PICC NEONATE BD FIRST PICC
• 20801741082898: SL PICC II UNIV NEONATE SMALL CHANNEL
• 10801741082877: SL PICC II BD/TYCO
• 10801741082860: SL PICC VYGON NEONATE
• 10801741082365: SL IV ULTRA PEDIATRIC SEPP AMP
• 10801741082358: DOT SL IV ULT KIT SEPP W/ALCOHOL
• 10801741082327: SL IV UNIV
• 20801741082317: SL IV ULLTRA BD NEXIVA
• 20801741082300: SL IV ULTRA ACUVANCE
• 10801741082297: SL IV ULTRA NT PED
• 20801741082287: SL IV ULTRA NT
• 10801741082150: SL IV PREM MACRO RETRACT BAXTER
• 20801741082133: SL IV PREM MICRO FIXED BAXTER
• 20801741082096: SL IV PREM OPTION-LOK
• 20801741082089: SL IV PREM KIPP MACRO
• 10801741082075: SL IV PREM KIPP MICRO
• 20801741081891: SL IVSELCT NOEXTSETREPL IV0521 OR IV525
• 20801741081761: SL IV ULTRA NEONATE BLUE
• 10801741081757: SL IV ULTRA PEDS
• 20801741081686: SL IV PLUS NO EXT SET
• 10801741081672: SL IAB TRICOT CRESC
• 20801741081570: SL CV ULTRA DUAL PT TETHERED LOCKNG CAPS
• 10801741081559: SL CV PLUS TRICOT CRESC SLIDING POST
• 20801741081525: SL CV PLUS W/PIGTAIL FIX POST
• 00801741083075: StatlockTM Stabilization devices (PICC, Crescent Pad, Posted Retainer with Clip)
• 00801741083402: StatlockTM Stabilization devices (PICC Plus, Pediatric, Teddy Bear Foam Pad, Sliding Post Retai