FDA.reportPublic FDA data

Hopkins Medical Products®

Primary DI
00817643021169
Brand
Hopkins Medical Products®
Company
HOPKINS UNIFORM COMPANY
Model
716266
Catalog number
716266
Device description
Hopkins Newborn & Mom Pulse Ox Kit w/Royal Case
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
DQAOximeter

Product Code Classifications

CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817643021169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817643021169008176430211698176430211690817643021169

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
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 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 DIBrandCompanyProduct codePublished
10884521091986NellcorCovidien LPDQA2026-05-25
06946725571460APKAPK Technology Co.,Ltd.DQA2026-05-22
06946725549926APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549933APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549940APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550021APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550038APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550045APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550069APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550076APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550083APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550090APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550106APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550113APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550137APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550144APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550151APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550168APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550182APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550199APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550205APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550212APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550229APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550236APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550243APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550250APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550267APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550274APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550281APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550298APKAPK Technology Co.,Ltd.DQA2026-03-19