Critikon

GUDID 30817357021395

Critikon Soft Cuf Two Tube Submin, Child

HYGIA HEALTH SERVICES, INC.

Blood pressure cuff, reprocessed

• Primary Device ID: 30817357021395
• NIH Device Record Key: c0dcc2d4-c127-4c59-ab32-d1233309f134
• Commercial Distribution Discontinuation: 2019-02-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Critikon
• Version Model Number: 2402
• 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	10817357021391 [Primary]
GS1	30817357021395 [Package]; Contains: 10817357021391; 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: 2016-09-28

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