AMG

GUDID 10810069260393

ARROW MEDSOURCE GROUP LIMITED

General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: 10810069260393
• NIH Device Record Key: 25fa6a8a-9734-43ea-b189-7272e5f29885
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMG
• Version Model Number: 6013
• Company DUNS: 686378503
• Company Name: ARROW MEDSOURCE GROUP LIMITED
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810069260396 [Primary]
GS1	10810069260393 [Package]; Contains: 00810069260396; Package: Box [100 Units]; In Commercial Distribution
GS1	20810069260390 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193526

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-17
• Device Publish Date: 2021-03-09

On-Brand Devices [AMG]

• 00850017650237: 2023
• 10850017650364: ASTM LEVEL 3 MASK WITH EYESHIELD
• 10850017650357: ASTM LEVEL 2 MASK WITH EYESHIELD
• 10850017650340: BOUFFANT CAPS, REGULAR, XL
• 10850017650333: COVER GOWNS, AAMI LEVEL 2, YELLOW, XL
• 10850017650326: COVER GOWNS, AAMI LEVEL 2, YELLOW, UNIVERSAL
• 10850017650302: BOUFFANT CAPS, PREMIUM, XL
• 10850017650296: COVERALL ANTI-STATIC, WHITE, 45g SMS, XL
• 10850017650272: THIN NITRILE EXAM GLOVES-XL
• 10850017650227: THIN NITRILE EXAM GLOVES-S
• 10850017650210: THIN NITRILE EXAM GLOVES-XS
• 20850017650071: SHOE COVERS, X-LARGE
• 20850017650064: SHOE COVERS, UNIVERSAL
• 30850017650054: COVER GOWNS, AAMI LEVEL 2, YELLOW, UNIVERSAL
• 10850017650258: 2024
• 10850017650234: 2023
• 20850017650149: NITRILE EXAM GLOVES-L
• 20850017650132: NITRILE EXAM GLOVES-M
• 20850017650125: NITRILE EXAM GLOVES-S
• 00850017650275: 2025
• 10850017650524: AMF2103-L3
• 10850017650517: AMF2103-L2
• 10850017650654: COVER GOWNS, BLUE, UNIVERSAL
• 20850017650644: COVER GOWNS, BLUE, UNIVERSAL
• 00850017650619: SCRUB PANTS, BLUE, XXXL
• 10850017650609: SCRUB PANTS, BLUE, XL
• 10850017650586: SCRUB PANTS, BLUE, M
• 10850017650562: SCRUB TOPS, BLUE, XXXL
• 10850017650555: SCRUB TOPS, BLUE, XXL
• 10850017650548: SCRUB TOPS, BLUE, L
• 10850017650531: CHEMO GOWNS, BLUE, XL
• 10850017650791: ALC0001XXL
• 10850017650777: ALC0001L
• 10850017650753: ALC0001M
• 10850017650739: ALC0001S
• 10850017650715: AGG0001
• 10850017650692: BC0001
• 10850017650678: SCP0001
• 00810069260334: 9500-N95
• 00810069260181: 1325
• 10810069260355: 6002
• 10810069260393: 6013
• 10810069260386: 6012
• 10810069260379: 6011
• 10810069260362: 6003
• 00810069260341: 6001
• 10850017650999: SP001XXL
• 10850017650982: SP001L
• 10850017650968: SP001S
• 10850017650937: ST001XL