Pedi-Lim Coaxial Circuit

GUDID 10709078009454

Pedi-Lim, 60" Pediatric Coaxial Circle Anesthesia Breathing Circuit W/24" Flex Expiratory Lead, GSE W/Cap, B/V Filter, 2L Not Made With Latex Breathing Bag, 10' x 0.050 M/M GSL

WESTMED, INC.

Anaesthesia breathing circuit, single-use

• Primary Device ID: 10709078009454
• NIH Device Record Key: ca2fc647-971e-4850-a1b3-430d60edcc07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pedi-Lim Coaxial Circuit
• Version Model Number: 9169
• Company DUNS: 092673953
• Company Name: WESTMED, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078009457 [Primary]
GS1	10709078009454 [Package]; Contains: 00709078009457; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922492

FDA Product Code

• OFP: Anesthesia Breathing Circuit Kit (Adult & Pediatric)

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: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [Pedi-Lim Coaxial Circuit]

• 10709078007573: 72" Pedi-Lim, Angled HMEF, 1L Not made with Latex, 48" Drop Line
• 10709078007566: Anesthesia Circuit,Pedi-Lim™ 60",Angled HMEF,1LF,48" Dropln
• 10709078009454: Pedi-Lim, 60" Pediatric Coaxial Circle Anesthesia Breathing Circuit W/24" Flex Expiratory Lead,