FDA.reportPublic FDA data

Nonin

Primary DI
00833166008722
Brand
Nonin
Company
NONIN MEDICAL, INC.
Model
2500C
Device description
charger stand
Published
2017-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQAScale, Surgical Sponge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQAScale, Surgical SpongeGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00833166008722PackageGS11In Commercial Distribution
00849686073669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00833166008722008331660087228331660087220833166008722
00849686073669008496860736698496860736690849686073669

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
763 553 9968Regulatory@nonin.com

Regulatory Flags#

DUNS number
174959692
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00833166000597NoninSAL-T-CONN2016-09-07
00849686072068Nonin9840AAT2016-08-24
00849686072129NoninLS1R2016-08-24
00849686072181NoninLS1-9R2016-08-24
00849686072204NoninLS1R-9R2016-08-24
00849686072600NoninCapno SW2017-03-13
00849686074307Nonin98432016-08-24
00849686074482Nonin9840SA2016-08-24
00849686071092Nonin9840AAT2016-09-03
00849686072136NoninLS12016-08-24
00849686052367MODEL 3150, WRIST-OX2, BLE31502024-11-21
00849686051698HANDHELD PULSE OXIMETER8500, PULSE OXIMETER2024-09-17
00849686065855HANDHELD PULSE OXIMETER2500C, PULSE OXIMETER CHARGER2024-09-17
00849686066524Reusable Finger Clip Pulse Oximetry Sensors8000AA, FINGER CLIP SENSOR 1M2024-09-17
00849686070637RESUSABLE PULSE OXIMETRY SENSOR SYSTEM8100Q2, REUSABLE EAR CLIP SENSOR2024-09-17
00849686085976REUSABLE PULSE OXIMETRY SOFT SENSORS70276, MODEL 8000JFW ADULT FLEXW DISP2024-09-17
00833166000122PALMSAT HANDHELD OXIMETER2500,8000SM2024-09-10
00833166000139PALMSAT HANDHELD OXIMETER2500, 8000SM-32024-09-10
00833166000146PALMSAT HANDHELD OXIMETER2500, 8000SL2024-09-10
00833166004410RESUSABLE PULSE OXIMETRY SENSOR SYSTEMEMBLA 8000J 3M2024-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850013361441Doran ScalesDORAN SCALES, INC.FQA2023-11-14
0078755101230950500 Sponge Counter Bag BlueXODUS MEDICAL, INC.FQA2022-12-08
0078755101234750510 Single Dispenser Rack Two Sets of Hooks In Front Wall & IV PoleXODUS MEDICAL, INC.FQA2022-12-08
0078755101235450511 Double Dispenser Rack Four Sets of Hooks IV Pole OnlyXODUS MEDICAL, INC.FQA2022-12-08
0078755101239250600 Sponge Counter Bags ClearXODUS MEDICAL, INC.FQA2022-12-08
00850013361250Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361267Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361274Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361281Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361298Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361304Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361403Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361410Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361427Doran ScalesDORAN SCALES, INC.FQA2022-05-31
08300496042235SOLIDEACALZIFICIO PINELLI SRLFQA2020-07-22
00809161142709DetectoCARDINAL SCALE MANUFACTURING COMPANYFQA2017-10-18
00809161201901DetectoCARDINAL SCALE MANUFACTURING COMPANYFQA2017-10-18
00849686073669NoninNONIN MEDICAL, INC.FQA2017-02-22