FDA.reportPublic FDA data

Hopkins Medical Products®

Primary DI
00817643021022
Brand
Hopkins Medical Products®
Company
HOPKINS UNIFORM COMPANY
Model
695272
Catalog number
695272
Device description
Large Adult Vital Sign Kit w/Single Patient Oximeter
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

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
00817643021022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817643021022008176430210228176430210220817643021022

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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
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
00817643023071Hopkins Medical Products Handheld Pulse OximeterY Probe5948102022-05-06
10817643020145Hopkins Medical Products®19696196962018-09-28
10817643020534Hopkins Medical Products®6951986951982018-09-27
00817643020148Hopkins Medical Products®19939199392018-09-28
00817643020537Hopkins Medical Products®6951976951972018-10-01
00817643021558Hopkins Medical Products®20705207052018-09-28
00817643021596Hopkins Medical Products®6906066906062018-09-28
00817643021602Hopkins Medical Products®6906076906072018-09-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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