FDA.reportPublic FDA data

Scientific Series™

Primary DI
00816394020322
Brand
Scientific Series™
Company
HELMER, INC.
Model
SLR104-ADA
Device description
Laboratory/Pharmacy Refrigerator - Undercounter, 4 cu ft
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSERefrigerator, Freezer, Blood Storage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSERefrigerator, Freezer, Blood StorageHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816394020322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816394020322008163940203228163940203220816394020322

GMDN Terms#

Term, Definition table
TermDefinition
Blood refrigeratorAn electrically-powered device intended to be used to store and/or transport whole blood and blood components (e.g., blood cells, plasma) while keeping them cold (temperatures from 1° to 6° Celsius). It may include handles and/or wheels for transportation, and alarms which signal unintentional changes in temperature and power failures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
317-773-9073techservice@helmerinc.com

Regulatory Flags#

DUNS number
086685682
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00816394021824FarrarFCF1332025-01-10
00816394021664HelmerPC4200-Pro2022-12-30
00816394021695i.Series®iBX020-GX51100202023-10-06
00816394021770i.Series®iBX080-GX2023-10-02
00816394021671i.Series Platelet IncubatorPC3200-PRO2022-12-01
00816394021688i.Series Platelet IncubatorPC2200-Pro2022-12-01
00816394020940i.Series®PC100-Pro2019-02-08
00816394020957i.Series®PC900-Pro2019-02-08
00816394020964i.Series®PC1200-Pro2019-02-08
00816394020971i.Series®PF15-Pro2019-02-08
00816394020988i.Series®PF48-Pro2019-02-08
00816394020995i.Series®PF96-Pro2019-02-08
00816394021053Horizon Series™HBR105-GXN/A2019-01-31
00816394021060i.Series®iLR105-GX2019-01-31
00816394021077Horizon Series™HLR105-GX2019-01-31
00816394021084i.Series®iPR105-GX2019-01-31
00816394021091Horizon Series™HPR105-GX2019-01-31
00816394021107i.Series®iBR113-GX2019-01-31
00816394021114Horizon Series™HBR113-GX2019-01-31
00816394021121i.Series®iLR113-GX2019-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260688580331KirschPhilipp Kirsch GmbHKSE2026-03-04
04260688580348KirschPhilipp Kirsch GmbHKSE2026-03-04
04260688580317KirschPhilipp Kirsch GmbHKSE2026-02-23
04260688580324KirschPhilipp Kirsch GmbHKSE2026-02-23
00857117006957FollettFOLLETT CORPORATIONKSE2026-01-13
00857117006964FollettFOLLETT CORPORATIONKSE2026-01-13
00860015036803Expeditionary RefrigeratorTACTICAL MEDICAL SOLUTIONS, LLCKSE2026-01-07
00761101151694HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151700HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151717HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151786HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151793HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151809HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151816HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151823HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151830HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151847HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151854HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151861HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
00761101151878HEMOVAULT by ACCUCOLD FELIX STORCH, INC.KSE2025-07-20
10885380193316CARDINAL HEALTHCardinal Health 200, LLCKSE2025-04-15
00857117006933FollettFOLLETT CORPORATIONKSE2025-02-04
00857117006940FollettFOLLETT CORPORATIONKSE2025-02-04
06949573500644Haier BiomedicalQingdao Haier Biomedical Co LtdKSE2025-01-07
06949573563625Haier BiomedicalQingdao Haier Biomedical Co LtdKSE2025-01-07
00857117006872FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006889FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006896FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006902FollettFOLLETT CORPORATIONKSE2024-12-23
00857117006919FollettFOLLETT CORPORATIONKSE2024-12-23