BERRCOM

GUDID 56947656114660

Guangzhou Berrcom Medical Device Co., Ltd

Infrared patient thermometer, skin

• Primary Device ID: 56947656114660
• NIH Device Record Key: a3930bd8-c654-4d1d-9a41-5fdb0b6a1f31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BERRCOM
• Version Model Number: JXB-302
• Company DUNS: 529391821
• Company Name: Guangzhou Berrcom Medical Device 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06947656114665 [Primary]
GS1	56947656114660 [Package]; Contains: 06947656114665; Package: Cartoon [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130231

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-02
• Device Publish Date: 2023-12-25

On-Brand Devices [BERRCOM]

• 06947656112470: JXB-313
• 06947656112401: JXB-190
• 06947656112395: JXB-183
• 06947656112500: JXB-302
• 06947656112739: JXB-178
• 06947656112838: JXB-195
• 06947656112685: JXB-182
• 06947656112692: JXB-183
• 16947656113269: DT007
• 56947656112772: JXB-311
• 66947656113646: DT008
• 66947656114087: DT007
• 56947656113410: JXB-315
• 06947656112784: DT001
• 56947656114691: ET005
• 56947656114738: JXB-315
• 56947656114721: JXB-195
• 26947656114713: NC005
• 56947656114707: JXB-311
• 36947656114284: JXB-178
• 56947656114660: JXB-302
• 56947656115322: DT101
• 56947656115094: JXB-192
• 56947656115087: JXB-192
• 56947656114677: JXB-301
• 26947656115857: JXB-178
• 16947656115836: NC007
• 16947656115829: NC006
• 56947656115902: JXB-178
• 56947656116251: DT007