DEVICE: FingerClip (04036616009447)
Device Identifier (DI) Information
FingerClip
F-3222-12 OEM BCI
In Commercial Distribution
06-00-0233
EnviteC-Wismar GmbH
F-3222-12 OEM BCI
In Commercial Distribution
06-00-0233
EnviteC-Wismar GmbH
FingerClip F-3222-12 OEM BCI
Device Characteristics
MR Unsafe | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
37808 | Pulse oximeter probe, reusable |
A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQA | Oximeter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 5 and 40 Degrees Celsius |
Storage Environment Temperature: between -20 and 70 Degrees Celsius |
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 40 Millimeter |
Length: 140 Millimeter |
Width: 130 Millimeter |
Device Record Status
e5db36f4-9f63-4fc8-b273-cfb7424bd1ac
November 10, 2021
5
September 22, 2016
November 10, 2021
5
September 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined