UltiCare

GUDID 20357515094395

ULTIMED, INC.

Insulin syringe/needle, basic

• Primary Device ID: 20357515094395
• NIH Device Record Key: 57dbe80f-e518-444b-912b-d519d2b58fbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltiCare
• Version Model Number: 0439PL
• Company DUNS: 024723541
• Company Name: ULTIMED, INC.
• Device Count: 10
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00357515174390 [Unit of Use]
GS1	10357515174397 [Primary]
GS1	20357515074397 [Package]; Contains: 10357515174397; Package: UltiGuard [10 Units]; In Commercial Distribution
GS1	20357515084396 [Package]; Contains: 10357515174397; Package: Health Wise Box [10 Units]; In Commercial Distribution
GS1	20357515094395 [Package]; Contains: 10357515174397; Package: Box [10 Units]; In Commercial Distribution
GS1	20357515124399 [Package]; Contains: 10357515174397; Package: UltiGuard [10 Units]; In Commercial Distribution
GS1	20357515181323 [Package]; Contains: 10357515174397; Package: Healthy Accents Box [10 Units]; In Commercial Distribution
GS1	20357515910008 [Package]; Contains: 10357515174397; Package: 90ct-Box [9 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021983

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-09-24

On-Brand Devices [UltiCare]

• 00357515999993: 99999
• 20357515710127: 71012
• 20357515710110: 71011
• 20357515710103: 71010
• 20357515710097: 71009
• 20357515710080: 71008
• 20357515710073: 71007
• 20357515710066: 71006
• 20357515710059: 71005
• 20357515710042: 71004
• 20357515710035: 71003
• 20357515710028: 71002
• 20357515710011: 71001
• 20357515710004: 71000
• 20357515095859: 09585
• 20357515095835: 09583
• 20357515095651: 09565
• 20357515095637: 09563
• 20357515095453: 09545
• 20357515095439: 09543
• 20357515095125: 09512
• 20357515710158: 5mm Pen Needle UltiGuard
• 20357515710141: 6mm 32G pen needle
• 20357515710134: 5mm pen needle
• 20357515095620: 6mm 32G pen needle UltiGuard
• 20357515095538: 5mm pen needle UltiGuard
• 20357515093558: 0355PL
• 20357515093350: 0335PL
• 20357515093152: 0315PL
• 20357515094593: 09459
• 20357515094395: 0439PL
• 20357515094197: 09419
• 20357515910091: 0414PL
• 10357515950120: 0454PL
• 20357515910077: 0435PL
• 20357515910060: 0434PL
• 30357515610080: UltiCare Safety Pen Needle 8mm
• 30357515610059: UltiCare Safety Pen Needle 5mm
• 20357515460107: 10mL oral syringe
• 10357515460056: 5mL oral syringe
• 20357515460039: 3mL oral syringe
• 20357515460015: 1mL oral Syringe
• 20357515032595: insulin safety syringe with permanent attached needle .5cc, 29g, 1/2"
• 20357515032199: Insulin Safety Syringe with permanently attached needle 1cc, 29G, 1/2"