FDA.report

Hopkins Medical Products®

Primary DI
00817643021145
Brand
Hopkins Medical Products®
Company
HOPKINS UNIFORM COMPANY
Model
714019-BK
Catalog number
714019-BK
Device description
Hopkins Premium Clinician Starter Kit w/ Backpack
Published
2018-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817643021145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817643021145008176430211458176430211450817643021145

GMDN Terms

TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)835-1995customerservice@hopkinsmedical.net

Regulatory Flags

DUNS number
003080678
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00817643023071Hopkins Medical Products Handheld Pulse OximeterY Probe5948102022-05-06
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00817643021619Hopkins Medical Products®6906166906162018-09-28
00817643021626Hopkins Medical Products®6906176906172018-09-28
00817643021633Hopkins Medical Products®6985456985452018-09-28
00817643021640Hopkins Medical Products®698545LF698545LF2018-09-28
00817643021657Hopkins Medical Products®6985476985472018-09-28
00817643021664Hopkins Medical Products®698547LF698547LF2018-09-28
00817643020254Hopkins Medical Products®34268342682018-09-28
00817643022135Hopkins Medical Products®6102206102202018-09-28
00817643022241Hopkins Medical Products®6153506153502018-09-28
00817643022258Hopkins Medical Products®6200676200672018-09-28
00817643020155Hopkins Medical Products®34203342032018-09-28
00817643020162Hopkins Medical Products®34204342042018-09-28

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