FDA.reportPublic FDA data

Atom Phototherapy Analyzer Ⅱ

Primary DI
04942962684484
Brand
Atom Phototherapy Analyzer Ⅱ
Company
ATOM MEDICAL CORPORATION
Model
68448
Catalog number
68448
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04942962684484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04942962684484049429626844844942962684484

GMDN Terms#

Term, Definition table
TermDefinition
Photometer, reflectanceAn instrument that measures the amount of light emitted by a light source, e.g., a light-emitting diode, as reflected from a sample in order to determine the concentration of an element. The device usually contains a photodiode for light detection.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+81 488533661hitoshi.hayashi@atomed.co.jp

Regulatory Flags#

DUNS number
690632047
Device count
1
Premarket exempt
true
Serial number
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04942962613057V-707 with Power Pack(100-120V)61305613052016-09-21
04942962610858V-2200 Infant Incubator 61085610852024-10-29
04942962616102Neo-Servo i Atom Infant Incubator Model 10261610616102024-10-29
04942962674065V-2100G Advanced Infant Incubator 67406674062024-10-29
04942962603058Oxygen Sensor For V-80860305603052016-09-21
04942962603171Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR60317603172016-09-21
04942962608619Semi-Iris Access Port Cover(20 pcs/pkg)60861608612016-09-21
04942962615228V-808 Main Unit Only(120 V)61522615222016-09-21
04942962603706BILI-THERAPY Pad Type60370603702016-09-21
04942962603713Pad(L) For BILI-THERAPY Pad Type60371603712016-09-21
04942962603720Pad(S) For BILI-THERAPY Pad Type60372603722016-09-21
04942962603737Pad Cover(L) For BILI-THERAPY Pad Type(50 pcs/box)60373603732016-09-21
04942962603744Pad Cover(S) For BILI-THERAPY Pad Type(50 pcs/box)60374603742016-09-21
04942962603874Neo Cot HL Stand60387603872016-09-21
04942962261227Mattress Sheet for Neo Cot(5 pcs/pkg)26122261222016-10-28
04942962603218Mattress Sheets(5 pcs/pkg)60321603212016-09-21
04942962603867Patient Circuit60386603862015-09-08
04942962602983Test Bag, 50mL60298602982015-10-23
04942962603553Dispo Liner, 500mL For S401D, Suction Canister(30 pcs/box)60355603552016-09-21
04942962603621Resusci Flow Rail mounting type60362603622016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816467020402FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816870020006NeoLumax CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
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00816870020051NeoEldex ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020068PrisMatic ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020075Autoplex G1 ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020082Autoplex G2 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870024448Autoplex G3 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
07290016923063Auto Sampler (for BreathID Hp Lab System)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923384BreathID Hp Lab DeviceMERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923391BreathID Hp Lab Device (WIN)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
00860011967743ZELLECHEM-PROSTERILE SAFEQUIP & CHEMICALS LLPJJQ2024-07-09
04048474052527DRG:HYBRiD.XL®DRG Instruments Gesellschaft mit beschränkter HaftungJJQ2023-09-02
00840239052520DRG:HYBRiD.XL®DRG International IncJJQ2023-08-26
10810138822705EndocatorEndo Direct LLCJJQ2023-07-16
09120052071184SUNRISETecan Austria GmbHJJQ2023-07-06
09120052071191SUNRISE-RC/ST EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071207SUNRISE-RC/TW EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071214SUNRISE-RC/6F EVOLYZERTecan Austria GmbHJJQ2023-07-06
06936895300151BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300212BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
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00850229007010StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05