Orantech

GUDID 06941691974604

Philips Compatible, 5-Lead, IEC, 2.5M

Orantech Inc.

Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable

• Primary Device ID: 06941691974604
• NIH Device Record Key: a3d8a436-5d09-488f-9fc5-e62baec3876e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orantech
• Version Model Number: ET-5005R-SMA-I
• Company DUNS: 544423370
• Company Name: Orantech Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06941691974604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182327

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-18
• Device Publish Date: 2023-10-10

On-Brand Devices [Orantech ]

• 06941691966364: Used with Nellcor D-YS or Orantech multi-site sensors
• 06941691966357: Used with Masimo original multi-site sensors
• 06941691966340: Used with Nellcor D-YS or Orantech multi-site sensors
• 06941691966333: Used with Masimo original multi-site sensors
• 06941691966296: Used with Masimo original multi-site sensors
• 06941691965510: Zimmer Biomet Compatible Tourniquet dual hoses set of Blue dual hose/4m and Red dual hose/4m
• 06941691965503: Zimmer Biomet Compatible Tourniquet dual hose, Red, 4.0m
• 06941691965497: Zimmer Biomet Compatible Tourniquet dual hose, Blue,4.0m
• 06941691964841: Limb Clamp Electrode(Color:green), Adult, 4pcs/Set
• 06941691959915: Used with Nellcor D-YS or Orantech multi-site sensors
• 06941691946168: Suction Electrode Adapter Sets, 6pcs/Box
• 06941691946151: Suction Electrode Adapter Sets, 6pcs/Box
• 06941691946144: Limb Clamp Electrode(Color:red / black / green / yellow), Pediatric, IEC, 4pcs/Set
• 06941691946137: Limb Clamp Electrode(Color:white/green/red/black), Pediatric, AHA, 4pcs/Set
• 06941691946120: Limb Clamp Electrode (Color :red / black / green / yellow), Adult, IEC, 4pcs/Set
• 06941691946113: Limb Clamp Electrode Color white/green/red/black,Adult, AHA, 4pcs/Set
• 06941691924067: Nellcor-Oximax Compatible, 0.3M
• 06941691924043: Nellcor-Oximax Compatible, 1.2M
• 06941691924036: Nellcor Compatible, 2.4M
• 06941691924029: Nellcor Compatible, 1.2M
• 06941691925903: Invivo-Masimo Compatible, 2.4M
• 06941691925897: Invivo-Masimo Compatible, 2.4M
• 06941691925880: Invivo-Masimo Compatible, 2.4M
• 06941691925873: Invivo Compatible, 2.4M
• 06941691925866: Batex Compatible, 2.4M
• 06941691925859: Artema Compatible, 2.4M
• 06941691925842: Artema Compatible, 2.4M
• 06941691925835: Edan Compatible, 2.4M
• 06941691925828: Edan Compatible, 3.0M
• 06941691925811: Biolight-Oximax Compatible, 2.4M
• 06941691925804: Biolight-Oximax Compatible, 3.0M
• 06941691925798: Biolight Compatible, 2.4M
• 06941691925781: Biolight-Oximax Compatible, 2.4M
• 06941691925774: Biolight-Oximax Compatible, 3.0M
• 06941691925767: Biolight-Oximax Compatible, 2.4M
• 06941691925750: Biolight-Oximax Compatible, 3.0M
• 06941691925743: Biolight Compatible, 2.4M
• 06941691925736: Biolight Compatible, 2.4M
• 06941691925729: Goldway-Oximax Compatible, 2.4M
• 06941691925712: Goldway-Oximax Compatible, 3.0M
• 06941691925705: Goldway Compatible, 2.4M
• 06941691925699: Goldway Compatible, 2.4M
• 06941691925682: Goldway Compatible, 2.4M
• 06941691925675: Datascope Compatible, 2.4M
• 06941691925668: Mindray-Oximax Compatible, 2.4M
• 06941691925651: Mindray-Oximax Compatible, 3.0M
• 06941691925644: Mindray Compatible, 2.4M
• 06941691925637: Mindray Compatible, 2.4M
• 06941691925620: Mindray Compatible, 2.4M
• 06941691925613: Mindray-Masimo Compatible, 2.4M