DORA

GUDID 16948082746090

Bain Medical Equipment (Guangzhou) Co., Ltd.

Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle Haemodialysis needle

• Primary Device ID: 16948082746090
• NIH Device Record Key: a2487758-16b0-4531-8c70-74a32f4fbd34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORA
• Version Model Number: BAIN-A.V.F-005SE
• 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	06948082746093 [Primary]
GS1	16948082746090 [Package]; Contains: 06948082746093; Package: [50 Units]; In Commercial Distribution
GS1	26948082746097 [Package]; Package: [10 Units]; In Commercial Distribution

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: 2023-04-19
• Device Publish Date: 2023-04-11

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