Sunmed
GUDID 10889483042236
Opthalmoscope Lamp 3.5V
SUNMED, LLC
Direct ophthalmoscope, battery-powered| Primary Device ID | 10889483042236 |
| NIH Device Record Key | 4da7c4c4-211f-44f9-98ac-d619ae2afcb3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sunmed |
| Version Model Number | 5-0239-63 |
| Company DUNS | 069009268 |
| Company Name | SUNMED, LLC |
| 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 |
Customer Support Contacts
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com | |
| Phone | 800-433-2797 |
| info@sun-med.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
| Special Storage Condition, Specify | Between 0 and 0 *General Warehouse. Do not get wet. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10889483042236 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131719
FDA Product Code
| HLJ | Ophthalmoscope, Battery-Powered |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-29 |
On-Brand Devices [Sunmed]
| 10889483056523 | BATTERY COVER FOR SUNSTIM PLUS |
| 10889483056516 | BATTERY COVER FOR SUNSTIM |
| 10889483055564 | SUNSTIM PLUS OVERLAY |
| 10889483055557 | SUNSTIM OVERLAY |
| 20889483048105 | E/T TUBE CUFFED 2.5mm 10FR |
| 10889483042250 | Opthalmoscope Lamp 2.5V |
| 10889483042236 | Opthalmoscope Lamp 3.5V |
| 10889483042212 | Opthalmoscope Lamp 3.5V |
| 20889483041502 | TRACH TUBE CUFFED SZ 9.5mm |
| 20889483041496 | TRACH TUBE CUFFED SZ 9.0mm |
| 20889483041489 | TRACH TUBE CUFFED SZ 8.5mm |
| 20889483041472 | TRACH TUBE CUFFED SZ 8.0mm |
| 20889483041465 | TRACH TUBE CUFFED SZ 7.5mm |
| 20889483041458 | TRACH TUBE CUFFED SZ 7.0mm |
| 20889483041441 | TRACH TUBE CUFFED SZ 6.5mm |
| 20889483041434 | TRACH TUBE CUFFED SZ 6.0mm |
| 20889483041090 | REINFORCED E/T TUBE CUFFED 32FR |
| 20889483041083 | REINFORCED E/T TUBE CUFFED 30FR |
| 20889483041076 | REINFORCED E/T TUBE CUFFED 28FR |
| 20889483041069 | REINFORCED E/T TUBE CUFFED 26FR |
| 20889483041052 | REINFORCED E/T TUBE CUFFED 24FR |
| 20889483041045 | REINFORCED E/T TUBE CUFFED 22FR |
| 20889483041038 | REINFORCED E/T TUBE CUFFED 20FR |
| 20889483041021 | REINFORCED E/T TUBE CUFFED 18FR |
| 20889483041014 | REINFORCED E/T TUBE CUFFED 16FR |
| 20889483041007 | REINFORCED E/T TUBED CUFFED 14FR |
| 20889483040994 | REINFORCED E/T TUBE CUFFED 40FR |
| 20889483040765 | E/T TUBE CUFFED W/STYLET 8.5mm 34FR |
| 20889483040758 | E/T TUBE CUFFED W/STYLET 8.0mm 32FR |
| 20889483040741 | E/T TUBE CUFFED W/STYLET 7.5mm 30FR |
| 20889483040734 | E/T TUBE CUFFED W/STYLET 7.0mm 28FR |
| 20889483040727 | E/T TUBE CUFFED W/STYLET 6.5mm 26FR |
| 20889483040710 | E/T TUBE CUFFED W/STYLET 6.0mm 24FR |
| 20889483040703 | E/T TUBE CUFFED W/STYLET 5.5mm 22FR |
| 20889483040697 | E/T TUBE CUFFED W/STYLET 5.00mm 20FR |
| 20889483040680 | E/T TUBE CUFFED W/STYLET 4.5mm 18FR |
| 20889483040673 | E/T TUBE CUFFED W/STYLET 4.0mm 16FR |
| 20889483040666 | E/T TUBE CUFFED W/STYLET 3.5mm 14FR |
| 20889483040543 | E/T TUBE CUFFED 5.0mm 20FR |
| 20889483040536 | E/T TUBE CUFFED 4.5mm 18FR |
| 20889483040529 | E/T TUBE CUFFED 4.0mm 16FR |
| 20889483040512 | E/T TUBE CUFFED 3.5mm 14FR |
| 20889483040505 | E/T TUBE CUFFED 3.0mm 12FR |
| 20889483040499 | E/T TUBE CUFFED 10.0mm 40FR |
| 20889483040482 | E/T TUBE NO-CUFF 5.5mm 22FR |
| 20889483040475 | E/T TUBE NO-CUFF 5.0mm 20FR |
| 20889483040468 | E/T TUBE NO-CUFF 4.5mm 18FR |
| 20889483040451 | E/T TUBE NO-CUFF 4.0mm 16FR |
| 20889483040444 | E/T TUBE NO-CUFF 3.5mm 14FR |
| 10889483039038 | PEEP VALVE 5-20cm 30mm ID X 33mm OD |
Trademark Results [Sunmed]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUNMED 98691527 not registered Live/Pending |
Sunflora, Inc. 2024-08-09 |
 SUNMED 98651416 not registered Live/Pending |
Sunflora, Inc. 2024-07-16 |
 SUNMED 90825611 not registered Live/Pending |
Sunflora, Inc. 2021-07-13 |
 SUNMED 90285710 not registered Live/Pending |
Sunflora, Inc. 2020-10-29 |
 SUNMED 88498224 not registered Live/Pending |
Sunflora, Inc. 2019-07-02 |
 SUNMED 85381420 4111672 Live/Registered |
SunMed, LLC 2011-07-26 |
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