FDA.reportPublic FDA data

Disposable Sensor

Primary DI
04036616000581
Brand
Disposable Sensor
Company
Honeywell Healthcare Solutions GmbH
Model
DA-2221-1 BCI
Catalog number
08-00-0123
Device description
Disposable Sensor DA-2221-1 BCI
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992215000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992215000MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PEDEnvitec-Wismar GmbH2000-03-29DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04036616000581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04036616000581040366160005814036616000581

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, single-useA 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. The is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height105Millimeter
Length155Millimeter
Width210Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+493841360324christian.walsleben@honeywell.com

Regulatory Flags#

DUNS number
330943838
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04036616010948Oxygen SensorOOMLF102-M3E10026032020-03-03
04036616013895Oxygen SensorOOM113-ME10029542025-11-12
04036616010856Oxygen SensorOOMLF111-HE10025382025-04-28
04036616013871Oxygen SensorOOMLF204-DE10029522025-04-28
04036616007146Disposable SensorDA-2221-1 OEM BCI08-00-03232016-09-22
04036616010207Disposable sensorDA-2203-1 Nihon Kohden US10023242016-09-22
04036616001939SoftTip largeR-3212-31 Nellcor06-00-07092016-09-22
04036616001946SoftTip largeR-3222-12 BCI06-00-05842016-09-22
04036616002066SoftTip largeR-3512-40 Datex06-00-07272016-09-22
04036616002073SoftTip largeR-3512-9 Datex06-00-07662016-09-22
04036616002127SoftTip smallRS-2182-3 Minolta06-00-05912016-09-22
04036616002158SoftTip smallRS-2412 HP/Philips06-00-07262016-09-22
04036616002202SoftTip smallRS-3222-12 BCI06-00-05832016-09-22
04036616002257SoftTip smallRS-3412 Ohmeda06-00-07162016-09-22
04036616002264SoftTip smallRS-3412-10 Ohmeda06-00-08222016-09-22
04036616002295SoftTip smallRS-3512-40 Datex06-00-07292016-09-22
04036616002301SoftTip smallRS-3512-9 Datex06-00-08152016-09-22
04036616002349SoftTip® mediumRM-2182-3 Minolta06-00-13612016-09-22
04036616002370SoftTip® mediumRM-2412 HP/Phillips06-00-13642016-09-22
04036616002486SoftTip® mediumRM-3412 Ohmeda06-00-13772016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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