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Alaris Guardrails Editor 12.1.4
CAREFUSION 303, INC.
8961
In Commercial Distribution
- 10885403520020 ()
- Infusion pump medication-dosage application software
Alaris Systems Manager v12.5.2
CAREFUSION 303, INC.
9601
In Commercial Distribution
- 10885403519666 ()
- Infusion pump medication-dosage application software
Calculation Services 1.X
CAREFUSION 303, INC.
1.X
In Commercial Distribution
- 10885403510489 ()
- Infusion pump medication-dosage application software
Infusion Adapter (v1.7.X)
CAREFUSION 303, INC.
Infusion Adapter
In Commercial Distribution
- 10885403510472 ()
- Infusion pump medication-dosage application software
Orthex P&C Software v1.2
ORTHOPEDIATRICS CORP.
ORTHEXRPS
In Commercial Distribution
- 00841132179772 ()
ORTHEXRPS
- External orthopaedic fixation system, single-use
Top and Bottom Aligners
ARCADLAB
Clear Orthodontic Aligners
In Commercial Distribution
- 00860011071921 ()
- Orthodontic aligner auxiliary attachment kit
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution
- B553TEMPOSMART110 ()
- Home pharmaceutical management support software
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution
- B553TEMPOSMART100 ()
- Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution
- B553TEMPOINSIGHTS110 ()
- Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution
- B553TEMPOINSIGHTS100 ()
- Home pharmaceutical management support software
Click2Correct/ Smart Correction software
Wishbone Medical, Inc.
C2C20210
In Commercial Distribution
- B562C2C20210 ()
- External orthopaedic fixation frame calculation software
Orthex P&C Software v2
ORTHOPEDIATRICS CORP.
ORTHEXSW
In Commercial Distribution
- 00840194428002 ()
ORTHEXSW
- External orthopaedic fixation frame calculation software
No Description
LUXOTTICA GROUP SPA
AW5004656
In Commercial Distribution
- 08059820279921 ()
- Air-conduction hearing aid, spectacle
No Description
LUXOTTICA GROUP SPA
AW5004556
In Commercial Distribution
- 08059820279914 ()
- Air-conduction hearing aid, spectacle
No Description
LUXOTTICA GROUP SPA
AW5004456
In Commercial Distribution
- 08059820279907 ()
- Air-conduction hearing aid, spectacle
No Description
LUXOTTICA GROUP SPA
AW5004356
In Commercial Distribution
- 08059820279860 ()
- Air-conduction hearing aid, spectacle
No Description
LUXOTTICA GROUP SPA
AW5002648
In Commercial Distribution
- 08059820279792 ()
- Air-conduction hearing aid, spectacle
No Description
LUXOTTICA GROUP SPA
AW5002548
In Commercial Distribution
- 08059820279785 ()
- Air-conduction hearing aid, spectacle
No Description
LUXOTTICA GROUP SPA
AW5002448
In Commercial Distribution
- 08059820279778 ()
- Air-conduction hearing aid, spectacle
No Description
LUXOTTICA GROUP SPA
AW5002348
In Commercial Distribution
- 08059820279761 ()
- Air-conduction hearing aid, spectacle
No Description
LUXOTTICA GROUP SPA
AW5001654
Not in Commercial Distribution
- 08059820279679 ()
- Air-conduction hearing aid, spectacle
No Description
LUXOTTICA GROUP SPA
AW5001554
In Commercial Distribution
- 08059820279662 ()
- Air-conduction hearing aid, spectacle
No Description
LUXOTTICA GROUP SPA
AW5001454
In Commercial Distribution
- 08059820279655 ()
- Air-conduction hearing aid, spectacle
No Description
LUXOTTICA GROUP SPA
AW5001354
Not in Commercial Distribution
- 08059820279648 ()
- Air-conduction hearing aid, spectacle
Infusion Safety Management Software
BAXTER HEALTHCARE CORPORATION
DOSEIQW0001
In Commercial Distribution
- 00085412676616 ()
DOSEIQW0001
- Infusion pump medication-dosage application software
Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-07
In Commercial Distribution
- 00811505030450 ()
IMS
- Infusion pump medication-dosage application software
Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-06
In Commercial Distribution
- 00811505030443 ()
IMS
- Infusion pump medication-dosage application software
Infusion Management System (IMS)
Fresenius Kabi AG
030-0027-05
In Commercial Distribution
- 00811505030399 ()
IMS
- Infusion pump medication-dosage application software
Infusion Management System (IMS), version 4.0.0
Fresenius Kabi AG
4.0.0
In Commercial Distribution
- 00811505030351 ()
IMS-0700
- Infusion pump medication-dosage application software
Infusion Management System (IMS) Version 3.0.0
Fresenius Kabi AG
3.0.0
In Commercial Distribution
- 00811505030177 ()
IMS-0600
- Infusion pump medication-dosage application software