BUDDY LITE
GUDID 00896128002497
ASSY, BUDDY LITE BATTERY HOUSING AND HEATER UNIT
BELMONT INSTRUMENT CORPORATION
Conduction blood/fluid warmer| Primary Device ID | 00896128002497 |
| NIH Device Record Key | 5c4ec322-1b14-4eb1-b987-67049b764321 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BUDDY LITE |
| Version Model Number | 403-00340 |
| Company DUNS | 078330362 |
| Company Name | BELMONT INSTRUMENT CORPORATION |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 00896128002497 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090508
FDA Product Code
| BSB | Warmer, Blood, Non-Electromagnetic Radiation |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-03-22 |
| Device Publish Date | 2016-09-23 |
Devices Manufactured by BELMONT INSTRUMENT CORPORATION
| 07290107581301 - CritiCool Mini | 2024-04-24 CritiCool Mini Unit |
| 20896128002095 - buddy™ Disposable Set | 2024-04-23 6 X Box 24=144 |
| 17290012127332 - CureWrap™ Pediatric, 79-91cm (8 pack) | 2024-03-27 Accessory for the CritiCool system. |
| 00896128002077 - Hyperthermia Pump St In/Out Pt Line | 2024-02-19 |
| 00896128002169 - Hyperthermia Pump St In/Out Pt Line | 2024-02-19 |
| 00896128002176 - Hyperthermia Pump Accessory | 2024-02-19 |
| 00896128002190 - Hyperthermia Pump Accessory | 2024-02-19 |
| 00896128002237 - Hyperthermia Pump St In/Out Pt Line Kit w/ 3L Reservoir | 2024-02-19 |
Trademark Results [BUDDY LITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BUDDY LITE 90115138 not registered Live/Pending |
Belmont Instrument, LLC 2020-08-14 |
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