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Capsule Vitals Plus

FDA UDI

Class II (US FDA UDI)

by Philips North America LLC

Identity

Trade Name
Capsule Vitals Plus FDA UDI
Generic Name
Patient monitoring system module, interfacing FDA UDI
Device Name
Vitals Plus Backpack Thermometer Exergen FDA UDI
Vitals Plus Backpack Oximeter Masimo Capno Masimo FDA UDI
Vitals Plus Backpack Thermometer Exergen Capno Masimo FDA UDI
Vitals Plus Backpack Capno Masimo FDA UDI
Vitals Plus Backpack FDA UDI
Vitals Plus Backpack Oximeter Masimo FDA UDI
Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen FDA UDI
Vitals Plus Backpack Oximeter Masimo Thermometer Exergen FDA UDI
Vitals Plus Backpack Oximeter Masimo Thermometer Exergen Capno Masimo FDA UDI
Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen Capno Masimo FDA UDI
Vitals Plus Backpack Oximeter Nellcor FDA UDI
Model / Reference
CAP-VP-NIBPAH-MON-HW FDA UDI
Description
Vitals Plus Backpack Thermometer Exergen FDA UDI
Vitals Plus Backpack Oximeter Masimo Capno Masimo FDA UDI
Vitals Plus Backpack Thermometer Exergen Capno Masimo FDA UDI
Vitals Plus Backpack Capno Masimo FDA UDI
Vitals Plus Backpack FDA UDI
Vitals Plus Backpack Oximeter Masimo FDA UDI
Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen FDA UDI
Vitals Plus Backpack Oximeter Masimo Thermometer Exergen FDA UDI
Vitals Plus Backpack Oximeter Masimo Thermometer Exergen Capno Masimo FDA UDI
Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen Capno Masimo FDA UDI
Vitals Plus Backpack Oximeter Nellcor FDA UDI

Identifiers

Primary DI / UDI-DI
03615040001794 FDA UDI
03615040002524 FDA UDI
03615040002302 FDA UDI
03615040002517 FDA UDI
03615040001824 FDA UDI
03615040002456 FDA UDI
03615040002227 FDA UDI
03615040002500 FDA UDI
03615040001688 FDA UDI
03615040001985 FDA UDI
03615040002265 FDA UDI
03615040002562 FDA UDI
03615040001930 FDA UDI
03615040001992 FDA UDI
03615040002357 FDA UDI
03615040002425 FDA UDI
03615040001954 FDA UDI
510(k) Number
K210204 FDA UDI
FDA Product Code
MWI FDA UDI
DXN FDA UDI
DQA FDA UDI
FLL FDA UDI
CCK FDA UDI
GMDN Term
Patient monitoring system module, interfacing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
870.1130 FDA UDI
870.2700 FDA UDI
880.2910 FDA UDI
868.1400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDIFDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Patient monitoring system module, interfacing

Capsule Vitals Plus by Philips North America LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, interfacing.

Cleared under the same submission

K210204 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Philips North America LLC

Sources (17)

  • FDA UDI 2feec3d0-6cc9-4f4c-9326-cee85d1a433f 34 fields · synced Jun 8, 2026
  • FDA UDI 11ed1f36-606a-469f-9eff-ab3bdce8729b 34 fields · synced May 22, 2026
  • FDA UDI 0a91ea8d-9381-4a4e-9b52-47bd476bc549 34 fields · synced May 24, 2026
  • FDA UDI 077ceabc-1018-45dc-80f3-f1e464e93977 34 fields · synced May 24, 2026
  • FDA UDI 011e6e29-d194-4994-9bea-e74e5beaa147 34 fields · synced May 25, 2026
  • FDA UDI 91a6496d-74b1-4d19-b9ce-d2769d216705 34 fields · synced May 25, 2026
  • FDA UDI 471afc44-2cbb-4cc0-9613-ead21904156f 34 fields · synced May 25, 2026
  • FDA UDI 1239471e-a76d-4820-afb1-e54859ea2344 34 fields · synced May 25, 2026
  • FDA UDI 8f386d16-5d87-4400-b92d-ffde6c1b3f16 34 fields · synced May 25, 2026
  • FDA UDI 65770b60-aac6-4ff9-8fe3-7dd864a1f7fc 34 fields · synced May 25, 2026
  • FDA UDI cb1cf2b5-384b-4ce1-8968-5f8c9c19e8db 34 fields · synced May 25, 2026
  • FDA UDI 19eb1505-9979-4f48-b2eb-e98261362fd6 34 fields · synced May 25, 2026
  • FDA UDI ad3dbc66-e36a-46d3-a9ba-cab46693ddcc 34 fields · synced May 25, 2026
  • FDA UDI 70452474-dd09-445d-b3e6-4f53d5d4e5ff 34 fields · synced May 26, 2026
  • FDA UDI d650ccf7-c379-4320-9b94-358fc8c88e08 34 fields · synced May 26, 2026
  • FDA UDI 78c0c21b-8ec1-49ae-90c8-c39d01bc78eb 34 fields · synced May 27, 2026
  • FDA UDI de4ecf98-720d-4be1-8d41-cf75f6a6dcc3 34 fields · synced May 27, 2026