Biotronix Healthcare Syringes GE12027

GUDID 20858835007350

Disposable 60CC, LL Syringe W/O Needle, Each

BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Hypodermic needle, single-use

• Primary Device ID: 20858835007350
• NIH Device Record Key: b8feb6ac-bd7c-4315-812b-e7dfcd226e4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotronix Healthcare Syringes
• Version Model Number: GE12027
• Catalog Number: GE12027
• Company DUNS: 065762392
• Company Name: BIOTRONIX HEALTHCARE INDUSTRIES, 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

Customer Support Contacts

• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com
• Phone: 786-473-9436
• Email: mborges@biotronixhealthcare.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00858835007356 [Primary]
GS1	10858835007353 [Package]; Contains: 00858835007356; Package: Inner Box [25 Units]; In Commercial Distribution
GS1	20858835007350 [Package]; Contains: 10858835007353; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060211

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-24
• Device Publish Date: 2019-10-12

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• 00858835007301: Disposable 3CC, LL Syringe W/O Needle, Each
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• 20864085000409: Disposable 10CC, LL Syringe, W/Needle, 21G x 1 1/2", Each,
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• 00858835007394: Disposable .30CC Insulin Unibody Syringe, U-100, Needle 31G x 5/16", 10/Bag
• 20858835007367: Disposable 1/2CC Insulin Unibody Syringe, U-100, Needle 31G x 5/16", 10/Bag
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• 20858835007343: Disposable 30CC, LL Syringe W/O Needle, Each
• 20858835007336: Disposable 20CC, LL Syringe W/O Needle, Each
• 20858835007299: Disposable 10CC, LL Syringe, W/Needle, 21G x 1", Each
• 20858835007282: Disposable 10CC, LL Syringe, W/Needle, 20G x 1", Each
• 20858835007275: Disposable 5CC, LL Syringe W/Needle, 21G x 1 1/2", Each
• 20858835007268: Disposable 3CC, LL Syringe W/Needle, 23G x 1", Each
• 20858835007251: Disposable 3CC, LL Syringe W/Needle, 22G x 1 1/2", Each
• 20858835007244: Disposable 3CC, LL Syringe W/Neddle, 22G x 1", Each
• 20858835007237: Disposable 3CC, LL Syringe W/Needle, 21G x 1 1/2", Each
• 20858835007220: Disposable 3CC, LL Syringe W/Needle, 21G x 1", Each
• 20858835007213: Disposable 1CC Luer Slip Syringe, W/Needle 27G x 1/2",Each
• 20858835007206: Disposable 1CC Luer Slip Syringe, W/Needle 25G x 5/8", each
• 20858835007190: Disposable 1cc Insulin Unibody Syringe, U-100, W/Needle 31G x 5/16"
• 20858835007169: Disposable 1/2cc Insulin Unibody Syringe, U-100, W/Needle 30G x 5/16"
• 20850005165792: Disposable 3CC, LL Syringe W/Needle, 20G x 1", Each