Spectra MM100600

GUDID 08809108017727

Spectra wearable's accessory valve and check valve configuration

UZINMEDICARE CO.,LTD

Breast pump support kit, reusable

• Primary Device ID: 08809108017727
• NIH Device Record Key: 335f8ee1-0082-45e2-83c9-9f19cc230a39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectra
• Version Model Number: Spectra Wearable Accessory (valve, backflow protec
• Catalog Number: MM100600
• Company DUNS: 688451947
• Company Name: UZINMEDICARE 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809108017727 [Primary]
GS1	28809108017721 [Package]; Package: Carton box [240 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220926

FDA Product Code

• HGX: Pump, Breast, Powered

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: 2025-04-23
• Device Publish Date: 2025-04-15

On-Brand Devices [Spectra]

• 28809108014218: A collection of non-sterile items intended to be used in conjunction with the electric breast pu
• 28809108014201: A collection of non-sterile items intended to be used in conjunction with the electric breast pu
• 08809108013880: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108013761: This is placed in the bra, allowing moms to express breastmilk hands free. It is connected to ba
• 28809108013709: This is placed in the bra, allowing moms to express breastmilk hands free. It is connected to ba
• 28809108013310: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108013136: This is a funnel shaped accessory, which come in contact with breat to express milk.
• 28809108013143: This is a funnel shaped accessory, which come in contact with breat to express milk.
• 28809108013150: This is a funnel shaped accessory, which come in contact with breat to express milk.
• 28809108013167: This is a funnel shaped accessory, which come in contact with breat to express milk.
• 08809108012852: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108012610: This is a funnel shaped accessory, which come in contact with breat to express milk.
• 28809108012603: This is a funnel shaped accessory, which come in contact with breat to express milk.
• 28809108012597: This is a funnel shaped accessory, which come in contact with breat to express milk.
• 28809108012580: This is a funnel shaped accessory, which come in contact with breat to express milk.
• 28809108012573: A hand-held device used to extract milk from the breast, typically for collecting and feeding to
• 08809108012753: This is a funnel shaped accessory, which come in contact with breat to express milk. It is conne
• 08809108012685: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 08809108012678: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 08809108012661: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108012559: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108012542: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108012405: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 08809108012388: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 08809108012371: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 08809108012364: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108012351: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108012344: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108012320: This is a funnel shaped accessory, which come in contact with breat to express milk. It is conne
• 28809108012313: This is a funnel shaped accessory, which come in contact with breat to express milk. It is conne
• 08809108012302: This is a funnel shaped accessory, which come in contact with breat to express milk. It is conn
• 28809108011996: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 08809108011909: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108011569: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108011354: This is powered breast pump to be used by lactating women to express and collect milk from their
• 18809108011340: This is powered breast pump to be used by lactating women to express and collect milk from their
• 28809108011309: This is powered breast pump to be used by lactating women to express and collect milk from their
• 08809108011138: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 08809108011091: This is powered breast pump to be used by lactating women to express and collect milk from their
• 28809108010593: This is powered breast pump to be used by lactating women to express and collect milk from their
• 28809108010036: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108014331: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108014324: A collection of non-sterile items intended to be used in conjunction with the electric breast pu
• 28809108013778: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108013747: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108013402: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108014430: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108014423: A collection of non-sterile items intended to be used in conjunction with a manual or electric b
• 28809108014416: A collection of non-sterile items intended to be used in conjunction with the electric breast pu
• 28809108014409: A collection of non-sterile items intended to be used in conjunction with the electric breast pu