CARDINAL HEALTH SANHDATS16

GUDID 50197106840519

ARTERIAL TRAY SH 16061

Cardinal Health 200, LLC

Cardiothoracic surgical procedure kit, medicated, single-use

• Primary Device ID: 50197106840519
• NIH Device Record Key: 8cb9c0a4-5c67-44f4-a5d7-2e6544e4053b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARDINAL HEALTH
• Version Model Number: SANHDATS16
• Catalog Number: SANHDATS16
• Company DUNS: 961027315
• Company Name: Cardinal Health 200, LLC
• 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: true
• 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	10197106840511 [Primary]
GS1	50197106840519 [Package]; Contains: 10197106840511; Package: CASE [20 Units]; In Commercial Distribution

FDA Product Code

• OEZ: Cardiovascular procedure kit

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: 2024-12-04
• Device Publish Date: 2024-11-26

On-Brand Devices [CARDINAL HEALTH]

• 50630140034532: T-TUBE 19FR SILICONE
• 50630140033986: JP WALL SUCTION ADAPTER
• 20630140033978: DRAIN TO NON J-P RES CONNECTOR
• 50630140030220: Absorbent Towel
• 50630140020900: DRAIN JACKSON-PRT 15FR W/TROC
• 00630140020431: Temp-Aid Gel Sleeves/Covers for Multi-Purpose Hot/Cold Pack
• 50630140013810: Cardinal Health Cold Pack Instant, Medium
• 50887488044024: STERILE OR VASCULAR PACK
• 50887488044000: STERILE TRAUMA FFX KIT
• 50887488043256: KIT, 35027,ORTHO SPINE,AMC
• 50887488043201: STRL PEDIATRIC OFF PUMP PACK
• 50887488042495: STRL PEDIATRIC CRANIOTOMY PK
• 50887488042457: STERILE NEURO ADULT PACK
• 50887488042419: STERILE MAJOR UROLOGY TRAY
• 50887488042389: STERILE LIVER TRANSPLANT TRAY
• 50887488042310: STERILE CARDIOVASCULAR TRAY
• 50887488041924: STERILE EP PACK
• 50887488041641: STERILE CRANIOTOMY PACK
• 50887488041627: STERILE SOR OR TRACH PACK
• 50887488041603: STERILE BREAST PACK
• 50887488041566: MOD ,ANT CERV FSN VP SHUNT,KIT
• 50887488041504: MODULE, CRANIOTOMY, KIT
• 50887488041481: STERILE AV SHUNT PACK
• 50887488041313: KIT, PV PACK
• 50887488041252: STERILE VP SHUNT PACK
• 50887488041191: STERILE PED SPINE PACK
• 50887488041177: STRL OPSC FOOT ANKLE MINOR PK
• 50887488041146: STERILE HEAD AND NECK PACK
• 50887488041139: STERILE ENT TRACHEOTOMY PACK
• 50887488039839: CUSTOM ARTERIAL LINE KIT
• 50887488039686: STERILE ENDARTERECTOMIE PACK
• 50887488039587: STERILE ENS FEM POP
• 50887488039549: STERILE ENS AORTE THORACIQUE
• 50887488039136: 62725 BARCODE CRANI BACK PK
• 50887488039105: 62724 BARCODE PEDIATRIC SHUNT
• 50887488039051: STERILE ENS CRANIOTOMIE
• 50887488038993: STRL PEDIATRIC CARDIO CATH PK
• 50887488038931: STERILE ENS DE THORACOTOMIE
• 50887488038924: STERILE SHOULDER PACK
• 50887488038818: STERILE ANGIOGRAPHY PACK
• 50887488038245: STERILE NEUROENDOSCOPIC PACK
• 50887488038221: STERILE LUMBAR DISC PACK
• 50887488038153: KIT,ACL,SOUTHERN NM
• 50887488038108: STERILE CRANIOTOMY PACK
• 50887488037965: STERILE MASTOIDECTOMY PACK
• 50887488037866: STERILE TOTAL HIP PACK
• 50887488037842: STERILE NEURO PACK
• 50887488037750: STERILE LAP BAND PACK
• 50887488037446: STERILE GENERAL NEURO PACK
• 50887488037200: STERILE NEURO CUSTOM PACK