FDA.reportPublic FDA data

Roscoe Medical

Primary DI
80092237603822
Brand
Roscoe Medical
Company
Roscoe Medical
Model
50020
Device description
Pediatric Pulse Oximeter,
Published
2016-10-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80092237603822PackageGS1264Not in Commercial Distribution
00092237603826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8009223760382280092237603822
00092237603826000922376038260922376038260092237603826

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA 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). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-572-1962CustomerService@compasshealthbrands.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
022542271
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
80092237604225Wheelchair Foam Cushion - 22 x 18 x 3WCBF-22832020-11-11
80092237604232Wheelchair Foam Cushion - 24 x 18 x 3WCBF-24832020-11-11
80092237604300Wheelchair Back Cushion Foam - 16 x 17BKF-16172020-11-11
80092237604317Wheelchair Back Cushion Foam - 18 x 17BKF-18172020-11-11
80092237604324Wheelchair Back Cushion Foam - 20 x 19BKF-20192020-11-11
80092237604331Wheelchair Back Cushion Foam - 22 x 19BKFB-22192020-11-11
80092237604270Coccyx Cushion Memory Foam - 18 x 16 x 3COC-182020-11-11
80092237605468N/ADQ78442016-10-12
80092237611629N/ADQ84502016-10-12
80092237616655N/ADE75022016-10-12
80092237616686N/ADI47382016-10-12
80092237616709N/ADI81952016-10-12
80092237616754N/ADS22022016-10-12
80092237616761N/ADS50022016-10-12
80092237617515N/ADI37172016-10-12
80813520010772N/ADT30022016-10-12
80813520011939N/ADI10102016-10-12
80092237616440N/ADQ8000W52016-10-12
60092237603118Roscoe Medical500402016-10-05
80092237603181Roscoe Medical500182016-10-07

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Primary DI, Brand, Company table
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