Critikon

GUDID 30817357022309

Critikon Soft Cuf One Tube Bayonet, Thigh

HYGIA HEALTH SERVICES, INC.

Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed Blood pressure cuff, reprocessed

• Primary Device ID: 30817357022309
• NIH Device Record Key: 9c3611d7-18bf-443e-b1e1-51b3c5ca9e3f
• Commercial Distribution Discontinuation: 2019-02-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Critikon
• Version Model Number: 2365
• Company DUNS: 177939027
• Company Name: HYGIA HEALTH SERVICES, 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817357022305 [Primary]
GS1	30817357022309 [Package]; Contains: 10817357022305; Package: Box [20 Units]; Discontinued: 2021-03-19; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032821

FDA Product Code

• NPP: Reprocessed Blood Pressure Cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-03-19
• Device Publish Date: 2017-04-08

On-Brand Devices [Critikon]

• 30817357022323: Critikon Soft-Cuf 2-Tube Dinaclick Connector BP Cuff, Child Long
• 30817357022309: Critikon Soft Cuf One Tube Bayonet, Thigh
• 30817357022118: Critikon Soft Cuf One Tube Bayonet, Child
• 30817357021968: Critikon Soft Cuf Two Tube Submin, Large Adult
• 30817357021746: Critikon Soft Cuf Two Tube Submin, Thigh
• 30817357021586: Critikon Soft Cuf Two Tube Screw, Child
• 30817357021562: Critikon Soft-Cuf 2-Tube Dinaclick Connector BP Cuff, Small Adult Long
• 30817357021517: Critikon Soft Cuf Two Tube Submin, Small Adult
• 30817357021487: Critikon Soft Cuf Two Tube Screw, Large Adult Long
• 30817357021395: Critikon Soft Cuf Two Tube Submin, Child
• 30817357021180: Critikon Soft Cuf Two Tube Submin, Adult
• 30817357021081: Critikon Soft Cuf One Tube Bayonet, Large Adult
• 30817357021005: Critikon Soft Cuf Two Tube Screw, Adult Long
• 30817357020985: Critikon Soft Cuf One Tube Bayonet, Small Adult
• 30817357020824: Critikon Soft-Cuf 2-Tube Dinaclick Connector BP Cuff, Large Adult Long
• 30817357020787: Critikon Soft-Cuf 2-Tube Dinaclick Connector BP Cuff, Infant
• 30817357020763: Critikon Soft Cuf Two Tube Screw, Large Adult
• 30817357020756: Critikon Soft Cuf Two Tube Screw, Small Adult
• 30817357020428: Critikon Soft-Cuf 2-Tube Dinaclick Connector BP Cuff, Child
• 30817357020398: Critikon Soft Cuf One Tube Bayonet, Adult Long
• 30817357020244: Critikon Soft-Cuf 2-Tube Dinaclick Connector BP Cuff, Large Adult
• 30817357020237: Critikon Soft Cuf Two Tube Screw, Adult
• 30817357020220: Critikon Soft Cuf One Tube Bayonet, Adult
• 30817357020152: Critikon Soft-Cuf 2-Tube Dinaclick Connector BP Cuff, Small Adult
• 30817357020060: Critikon Soft-Cuf 2-Tube Dinaclick Connector BP Cuff, Adult
• 30817357020046: Critikon Soft-Cuf 2-Tube Dinaclick Connector BP Cuff, Adult Long