JOHN BUNN JB02020
GUDID M368020202
Finger Pulse Oximeter
GF HEALTH PRODUCTS, INC.
Pulse oximeter, battery-powered| Primary Device ID | M368020202 |
| NIH Device Record Key | 65427c57-d20a-415b-b75f-d2cc10da3027 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JOHN BUNN |
| Version Model Number | JB02020 |
| Catalog Number | JB02020 |
| Company DUNS | 132016168 |
| Company Name | GF HEALTH PRODUCTS, INC. |
| 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 | true |
| Manufacturing Date | false |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep at Room Temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M368020202 [Package] Contains: M368JB020201 Package: Box [136 Units] In Commercial Distribution |
| HIBCC | M368JB020201 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063641
FDA Product Code
| DQA | Oximeter |
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 | 2020-05-13 |
| Device Publish Date | 2020-05-05 |
On-Brand Devices [JOHN BUNN]
| M368020202 | Finger Pulse Oximeter |
| M368JB01120902 | Neb-u-Lite EV2 Nebulizer |
| M368JB01121112 | Neb-u-LiteLX3 Nebulite Compressor |
| M368325581 | Jackson Trachea Plug |
| M368325561 | Jackson Trachea Plug |
| M368325551 | Jackson Trachea Plug |
| M368325541 | Jackson Trachea Plug |
| M358325571 | Jackson Trachea Plug |
| M368GF642320 | TUBING O2 SURE-FLO 25', 25/CS |
| M368GF640410 | MASK 02W/7ft TUBING ADLT 50/CS |
| M368GF332420 | CANNULA NASAL W/ 25' TUBING |
| M368GF332390 | CANNULA NASAL W/7' TUBING |
| M368S1311 | ASPIRATOR W/ DLX STAND |
| M368JB01500861 | REGULATOR H CGA540 0-15 W/GAGE |
| M368JB01500831 | REGULATOR 0-8 W/GAUGE DISS |
| M368JB01500821 | REGULATOR 0-15 W/GAUGE YOKE ST |
| M368JB01500811 | REGULATOR 0-8 W/GAUGE YOKE STY |
| M368JB020171 | OxyRead Finger Pulse Oximeter |
| M368JB020081 | DigiOx Finger Pulse Oximeter |
| M368JB020071 | DigiOx Finger Pulse Oximeter |
| M368JB01121642 | NEB-U-TYKE RR TRAIN |
| M368JB01121101 | Neb-u-Lite LX Nebulizer Compressor |
| M368JB01120712 | Neb-u-Tyke Nebulizer Compressor |
| M368JB01120702 | NEB-U-TYKE NEB-A-DOODLE |
| M368JB01120672 | NEB-U-TYKE SPEEDSTER |
| M368JB01120622 | NEB-U-TYKE IC Penguin |
| M368JB01120612 | NEB-U-LITE EV |
| M368GF640952 | Nebulizer Set, Pediatric |
| M368GF614002 | Complete Nebulizer Set |
| M368GF613992 | Complete Nebulizer Set |
| M36857102 | Lumineb II Nebulizer Compressor |
| M368GF813702 | Mouthpiece, 22 mm |
Trademark Results [JOHN BUNN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 JOHN BUNN 74607936 2003945 Live/Registered |
GF HEALTH PRODUCTS, INC. 1994-12-06 |
 JOHN BUNN 74607932 1982067 Live/Registered |
GF HEALTH PRODUCTS, INC. 1994-12-06 |
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