Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Safety Guard Mattress Cover for Fall protection__80inX36inX6in_Bulk_N/S_12EA/CS
GRI Medical & Electronic Technology Co., Ltd.
SGS3680
In Commercial Distribution

  • 06931918183414 ()
  • 16931918183411 ()


  • Operating room turnover kit
Mattress cover_Heel slope_80in_12PCS
GRI Medical & Electronic Technology Co., Ltd.
HSM3680-COVER
In Commercial Distribution

  • 06931918177185 ()
  • 16931918177182 ()


  • Operating room turnover kit
Mattress cover_wing_80in_12ea/cs
GRI Medical & Electronic Technology Co., Ltd.
RP3680-COVER
In Commercial Distribution

  • 06931918177116 ()
  • 16931918177113 ()


  • Operating room turnover kit
Bariatric Mattress Cover_49inX85in_Bulk_N/S_12EA/CS
GRI Medical & Electronic Technology Co., Ltd.
BM4884-COVER
In Commercial Distribution

  • 06931918172357 ()
  • 16931918172354 ()


  • Operating room turnover kit
Safety Guard Mattress Cover for Fall protection__80inX36inX6in_Bulk_N/S_12EA/CS
GRI Medical & Electronic Technology Co., Ltd.
SGS3680-COVER
In Commercial Distribution

  • 06931918155398 ()
  • 16931918155395 ()


  • Operating room turnover kit
Transducer C9-4ec as part of Lumify 5.1 iOS
Philips Ultrasound LLC
300013145921
In Commercial Distribution

  • 00884838123762 ()


  • Rectal/vaginal ultrasound imaging transducer
AirStrip Cardiology, Patient Monitoring and OB - Client iOS
Airstrip Technologies, Inc.
2001
In Commercial Distribution

  • B15320010 ()


  • Bedside monitor remote-viewing software, physiological parameter
Sleep Apnea Notification Feature iOS (version 1.X)
APPLE INC.
Feature version 1.X
In Commercial Distribution

  • 00195949116209 ()


  • Self-care monitoring/reporting software
Also covers the following minor/medium updates: v3.1.0 (01)00860001471724(11)210526(10)310; v3.1.1 (01)00860001471724(11)210604(10)311; v3.1.2 (01)00860001471724(11)210625(10)312; v3.2.0 (01)00860001471724(11)210713(10)320; v3.2.1. (01)00860001471724(11)210804(10)321; v3.2.2 (01)00860001471724(11)210917(10)322; v3.2.3 (01)00860001471724(11)211026(10)323 ;v3.2.4 (01)00860001471724(11)211123(10)324; v3.7.0 (01)00860001471724(11) 221116(10)370; v3.6.2 (01)00860001471724(11) 221024(10)362; v3.4.0:(01)00860001471724(11)220609(10)350; v3.5.1(01)00860001471724(11)220718(10)351; v3.6.0 (01)00860001471724(11) 220926(10)360; v3.8.0 (01)00860001471724(11) 221215(10)380; v3.8.1 (01)00860001471724(11) 230127(10)381; v3.9.0 (01)00860001471724(11) 230217(10)390; v3.9.1 (01)00860001471724(11) 230417(10)391; v3.9.2 (01)00860001471724(11) 230609(10)392; v3.9.3 (01)00860001471724(11) 230714(10)393; v3.10.0 (01)00860001471724(11) 231013(10)3100
AMPLIFON SPA
iOS v3
In Commercial Distribution

  • 00860001471724 ()


  • Hearing aid/implant system remote control
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Apple iOS devices.
ELI LILLY AND COMPANY
MA7723 IOS
In Commercial Distribution

  • 00300021107550 ()
MA7723001AM

  • Medication reminder application software
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