FDA.report

Unimed

Primary DI
06945664899666
Brand
Unimed
Company
Unimed Medical Supplies, Inc.
Model
U523-07
Device description
Disposable blood oxygen probe/adhesion /Datascope/ children / 0.9m/PlusCare
Published
2021-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DQAOximeter

Product Code Classifications

CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06945664899666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06945664899666069456648996666945664899666

GMDN Terms

TermDefinition
Pulse oximeter probe, single-useA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). The is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
527971025
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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06936735488353UnimedD6-RT180D-I2025-09-26
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06936735496501UnimedD33-13161-I2025-03-28
06936735494200Unimed24155P2025-03-13
06936735494675Unimed24155P-I2025-03-13
06936735495214UnimedE10R/30-KAR-P2025-03-13
06936735496099UnimedE10R/30-KAR-P/I2025-03-13
06936735496570UnimedAD-KAR-2101482025-03-13
06936735450503UnimedU410B-372022-04-11
06936735450510Unimed U410E-1212022-04-11
06936735450527UnimedU110-65D2022-04-11
06936735450534UnimedPU410S-01P2022-04-11
06936735450541UnimedU410-2242022-04-11
06936735451463UnimedU4M10-08L(NPS)2022-05-27
06936735451470UnimedT533-49R2022-05-27
06936735451487UnimedU310-195P2022-05-27
06936735451500UnimedU103S-2542022-05-27
06936735454105Unimed GS DP-11/A2022-11-01
06936735454518Unimed PU110-46D2022-12-08
06936735454525Unimed PU903-2032022-12-09

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