Spectra
GUDID 28809108016465
This is powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with neccessary connecting parts including breast shield(flange), Silicone valve, tubing, backflow protector, bottle, and instruction for use, so the user can use the device right after receving them.
UZINMEDICARE CO.,LTD
Breast pump, electric| Primary Device ID | 28809108016465 |
| NIH Device Record Key | dd33b6ea-2c18-4338-bb79-5214dedd86df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spectra |
| Version Model Number | Spectra SG Portable |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809108016461 [Primary] |
| GS1 | 28809108016465 [Package] Contains: 08809108016461 Package: Carton box [2 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210124
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 | 2024-01-23 |
| Device Publish Date | 2024-01-15 |
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 |
Trademark Results [Spectra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPECTRA 98626806 not registered Live/Pending |
Pocuter Inc. 2024-07-01 |
 SPECTRA 98458535 not registered Live/Pending |
Tucci, Ellis A 2024-03-20 |
 SPECTRA 98439017 not registered Live/Pending |
Spectra Holdings Company LLC 2024-03-07 |
 SPECTRA 98397295 not registered Live/Pending |
ReversingLabs International GmbH 2024-02-08 |
 SPECTRA 98060673 not registered Live/Pending |
Spectra Ltd. 2023-06-27 |
 SPECTRA 98060670 not registered Live/Pending |
Spectra Ltd. 2023-06-27 |
 SPECTRA 97768106 not registered Live/Pending |
Tucci, Ellis A. 2023-01-25 |
 SPECTRA 97726441 not registered Live/Pending |
Spectra Capital, LLC 2022-12-21 |
 SPECTRA 97707807 not registered Live/Pending |
APRE INSTRUMENTS, INC. 2022-12-07 |
 SPECTRA 97349849 not registered Live/Pending |
Illinois Tool Works Inc. 2022-04-06 |
 SPECTRA 97284066 not registered Live/Pending |
Brainstorm Force US LLC 2022-02-25 |
 SPECTRA 97249504 not registered Live/Pending |
ALTIUM LLC 2022-02-02 |
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