NeoCheck

GUDID 20889483631680

NeoCheck Disposable Blood Pressure Cuff Neonatal

SALTER LABS

Blood pressure cuff, single-use

• Primary Device ID: 20889483631680
• NIH Device Record Key: 2d21375c-9b0d-4b39-bc51-524ac38c3322
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoCheck
• Version Model Number: ZNCC4601HP-10
• Company DUNS: 022721133
• Company Name: SALTER LABS
• 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: false
• 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	10889483631683 [Primary]
GS1	20889483631680 [Package]; Contains: 10889483631683; Package: Box [10 Units]; In Commercial Distribution
GS1	30889483631687 [Package]; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921997

FDA Product Code

• DXQ: Blood Pressure Cuff

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: 2024-12-09
• Device Publish Date: 2024-11-29

On-Brand Devices [NeoCheck]

• 20889483631710: NeoCheck Disposable Blood Pressure Cuff Neonatal
• 20889483631703: NeoCheck Disposable Blood Pressure Cuff Neonatal
• 20889483631697: NeoCheck Disposable Blood Pressure Cuff Neonatal
• 20889483631680: NeoCheck Disposable Blood Pressure Cuff Neonatal
• 20889483631673: NeoCheck Disposable Blood Pressure Cuff Neonatal