DORA

GUDID 26948082700617

Bain Medical Equipment (Guangzhou) Co., Ltd.

Haemodialysis needle

• Primary Device ID: 26948082700617
• NIH Device Record Key: 91d64f27-0759-4448-93a3-0a7d5dae854b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORA
• Version Model Number: BAIN-A.V.F-003SG
• Company DUNS: 526972767
• Company Name: Bain Medical Equipment (Guangzhou) Co., Ltd.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948082700613 [Primary]
GS1	16948082700610 [Package]; Contains: 06948082700613; Package: [50 Units]; In Commercial Distribution
GS1	26948082700617 [Package]; Contains: 16948082700610; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163025

FDA Product Code

• FIE: Needle, Fistula

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: 2019-11-25
• Device Publish Date: 2019-11-15

On-Brand Devices [DORA]

• 26948082700679: BAIN-A.V.F-009SG
• 26948082700693: BAIN-A.V.F-011SG
• 26948082700655: BAIN-A.V.F-007SG
• 26948082700631: BAIN-A.V.F-005SG
• 26948082700617: BAIN-A.V.F-003SG
• 26948082700594: BAIN-A.V.F-001SG
• 16948082749701: BAIN-A.V.F-051SE
• 16948082749695: BAIN-A.V.F-007SE
• 16948082749688: BAIN-A.V.F-003SE
• 16948082746113: BAIN-A.V.F-049SE
• 06948082746109: BAIN-A.V.F-009SE
• 16948082746090: BAIN-A.V.F-005SE
• 16948082746083: BAIN-A.V.F-001SE