GIRAFFE PANDA DISPOSABLE SKIN TEMPERATURE

GUDID 00195278358363

GIRAFFE PANDA DISPOSABLE INFANT SKIN TEMPERATUR PROBE

DATEX-OHMEDA INC

General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use

• Primary Device ID: 00195278358363
• NIH Device Record Key: f357c676-97a1-448a-bc21-c0a045d77595
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GIRAFFE PANDA DISPOSABLE SKIN TEMPERATURE
• Version Model Number: NA
• Company DUNS: 080887689
• Company Name: DATEX-OHMEDA INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• 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

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278358363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123309

FDA Product Code

• FMZ: INCUBATOR, NEONATAL

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: 2021-11-18
• Device Publish Date: 2021-11-10

Devices Manufactured by DATEX-OHMEDA INC

• 00840682143677 - Giraffe In-Bed Scale: 2023-06-19 ASSY-LAU, GIRAFFE IN-BED SCALE, Finished good - Buy
• 00840682143721 - Panda In-Bed Scale: 2023-06-19 ASSY-LAU, PANDA IN-BED SCALE, Finished good - Buy
• 00840682145596 - Carestation 750: 2023-04-12 CARESTATION 750 A1
• 00840682146425 - Carestation 750c: 2023-04-12 CARESTATION 750c A1
• 00840682143684 - IV POLE ASSY 12 IN: 2022-12-14 IV POLE 12 IN
• 00840682143691 - ROTATING IV POLE: 2022-12-14 ROTATING IV POLE
• 00840682143707 - IV POLE ASSY 24 IN: 2022-12-14 IV POLE 24 IN
• 00195278579157 - ET CONTROL OPTION: 2022-07-29 ET CONTROL OPTION