JOHN BUNN

GUDID M36857102

Lumineb II Nebulizer Compressor

GF HEALTH PRODUCTS, INC.

Benchtop nebulizer, non-heated
Primary Device IDM36857102
NIH Device Record Key2e0cb853-bc5d-495f-8e1e-1b3961398076
Commercial Distribution StatusIn Commercial Distribution
Brand NameJOHN BUNN
Version Model Number5710
Company DUNS132016168
Company NameGF HEALTH PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com
Phone770-368-4700
Emailcs@grahamfield.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM36857101 [Primary]
HIBCCM36857102 [Package]
Contains: M36857101
Package: [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTICompressor, Air, Portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-06-10
Device Publish Date2016-08-31

On-Brand Devices [JOHN BUNN]

M368020202Finger Pulse Oximeter
M368JB01120902Neb-u-Lite EV2 Nebulizer
M368JB01121112Neb-u-LiteLX3 Nebulite Compressor
M368325581Jackson Trachea Plug
M368325561Jackson Trachea Plug
M368325551Jackson Trachea Plug
M368325541Jackson Trachea Plug
M358325571Jackson Trachea Plug
M368GF642320TUBING O2 SURE-FLO 25', 25/CS
M368GF640410MASK 02W/7ft TUBING ADLT 50/CS
M368GF332420CANNULA NASAL W/ 25' TUBING
M368GF332390CANNULA NASAL W/7' TUBING
M368S1311ASPIRATOR W/ DLX STAND
M368JB01500861REGULATOR H CGA540 0-15 W/GAGE
M368JB01500831REGULATOR 0-8 W/GAUGE DISS
M368JB01500821REGULATOR 0-15 W/GAUGE YOKE ST
M368JB01500811REGULATOR 0-8 W/GAUGE YOKE STY
M368JB020171OxyRead Finger Pulse Oximeter
M368JB020081DigiOx Finger Pulse Oximeter
M368JB020071DigiOx Finger Pulse Oximeter
M368JB01121642NEB-U-TYKE RR TRAIN
M368JB01121101Neb-u-Lite LX Nebulizer Compressor
M368JB01120712Neb-u-Tyke Nebulizer Compressor
M368JB01120702NEB-U-TYKE NEB-A-DOODLE
M368JB01120672NEB-U-TYKE SPEEDSTER
M368JB01120622NEB-U-TYKE IC Penguin
M368JB01120612NEB-U-LITE EV
M368GF640952Nebulizer Set, Pediatric
M368GF614002Complete Nebulizer Set
M368GF613992Complete Nebulizer Set
M36857102Lumineb II Nebulizer Compressor
M368GF813702Mouthpiece, 22 mm

Trademark Results [JOHN BUNN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
JOHN BUNN
JOHN BUNN
74607936 2003945 Live/Registered
GF HEALTH PRODUCTS, INC.
1994-12-06
JOHN BUNN
JOHN BUNN
74607932 1982067 Live/Registered
GF HEALTH PRODUCTS, INC.
1994-12-06

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