Edan Instruments, Inc. devices, product family

by Edan Instruments, Inc.and 1 other manufacturer record 24 variants Basic UDI-DI 69444138NIBPCUFFJ4

Shared by every variant

Manufacturer: Edan Instruments, Inc.(12)Edan Instruments,Inc.(12)
Several manufacturer records share this Basic UDI-DI.
Basic UDI-DI: 69444138NIBPCUFFJ4
Risk class: Class IClass II (varies)
Legislation: MDR
EMDN category: VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
Market status: 24 on the market
Official record: EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 69444138NIBPCUFFJ4.

Recalls

6 recalls · 5 ongoing · FDA

Z-1149-2026 Class II · ongoing · 24 Oct 2025
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-1145-2026 Class II · ongoing · 24 Oct 2025
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-1143-2026 Class II · ongoing · 24 Oct 2025
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-1144-2026 Class II · ongoing · 24 Oct 2025
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-1148-2026 Class II · ongoing · 24 Oct 2025
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-2388-2016 Class II · terminated · 23 Jun 2016
Incorrect CO2 readings with some patient monitors.

Recalls matched to the 24 devices listed on this page; other pages of the family can carry others.

Variants

24 devices · page 1 of 1

Variants of Edan Instruments, Inc. devices, Basic UDI-DI 69444138NIBPCUFFJ4
		UDI-DI	Size and differences
NIBP Cuff Edan Instruments,Inc.	A10	06944413817197	—	On the market
NIBP Cuff Edan Instruments,Inc.	A11	06944413817203	—	On the market
NIBP Cuff Edan Instruments,Inc.	A5	06944413817135	—	On the market
NIBP Cuff Edan Instruments,Inc.	A6	06944413817142	—	On the market
NIBP Cuff Edan Instruments,Inc.	A7	06944413817159	—	On the market
NIBP Cuff Edan Instruments,Inc.	A8	06944413817166	—	On the market
NIBP Cuff Edan Instruments,Inc.	A9	06944413817173	—	On the market
NIBP Cuff Edan Instruments,Inc.	A9L	06944413817180	—	On the market
NIBP Cuff Edan Instruments,Inc.	Adult E9	06944413841086	—	On the market
NIBP Cuff Edan Instruments,Inc.	Child E7	06944413841062	—	On the market
NIBP Cuff Edan Instruments,Inc.	Infant E5	06944413804487	—	On the market
NIBP Cuff Edan Instruments,Inc.	Small adult E8	06944413841079	—	On the market
NIBP CUFF 01.57.471907 Edan Instruments, Inc.	01.57.471907	06944413811874	—	On the market
NIBP Cuff Child, 13cm-17cm, reusable Edan Instruments, Inc.	Child,13cm-17cm, reusable	06944413804494	—	On the market
NIBP Cuff Child, 16cm-21.5cm, reusable Edan Instruments, Inc.	Child,16cm-21.5cm, reusable	06944413804500	—	On the market
NIBP Cuff Child, 16cm-21.5cm, reusable Edan Instruments, Inc.	Child,16cm-21.5cm, reusable	06944413804579	—	On the market
NIBP Cuff Larger Adult, 34cm-43cm, reusable Edan Instruments, Inc.	Larger Adult, 34cm-43cm, reusable	06944413804609	—	On the market
NIBP Cuff Neonatal, 10cm-15cm, reusable Edan Instruments, Inc.	Neonatal, 10cm-15cm, reusable	06944413804814	—	On the market
NIBP Cuff Neonatal, 6cm-11cm, reusable Edan Instruments, Inc.	Neonatal, 6cm-11cm, reusable	06944413804821	—	On the market
NIBP Cuff Small adult, 20.5cm-28cm, reusable Edan Instruments, Inc.	Small adult,20.5cm-28cm, reusable	06944413804517	—	On the market
NIBP Cuff Small Child, 13cm-17cm, reusable Edan Instruments, Inc.	Small Child,13cm-17cm, reusable	06944413804562	—	On the market
NIBP Cuff Thigh, 42cm-54cm, reusable Edan Instruments, Inc.	Thigh, 42cm-54cm, reusable	06944413804548	—	On the market
NIBP Cuff Thigh, 42cm-54cm, reusable Edan Instruments, Inc.	Thigh, 42cm-54cm,reusable	06944413804616	—	On the market
RespArray NIBP cuff 02.57.225235 Edan Instruments, Inc.	02.57.225235	06944413839496	—	On the market