FDA.reportPublic FDA data

ACS Combo-B Incubator

Primary DI
08800080220068
Brand
ACS Combo-B Incubator
Company
BSL Co.,Ltd
Model
ACS-102A
Published
2023-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNLContainer, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNLContainer, Specimen Mailer And Storage, Temperature Controlled, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800080220068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800080220068088000802200688800080220068

GMDN Terms#

Term, Definition table
TermDefinition
Aerobic laboratory incubatorA mains electricity (AC-powered) device heated by electrical currents passing through a heating block containing simple resistors (usually coils of nickel-chromium wire) for the purpose of growing microorganisms and cells that require oxygen (O2) for growth. Aerobic incubators are typically used for serology and crystallization studies, tissue culture work, paraffin wax embedding and in vitro fertilization (IVF).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+82553289235bsl@biosl.com

Regulatory Flags#

DUNS number
694860273
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800080220013ACS Combo-A CentrifugeACS-1012025-11-12
08800080211011Smart SyringeSKT-SS-1002023-05-11
08800080260019ATPU(Automatic Tissue Processing unit)ACPU-1002023-05-11
08800080200015Smart kit BasicSKT-0102023-05-11
08800080200022Smart kit BasicSKT-0202023-05-11
08800080200039Smart kit BasicSKT-0602023-05-11
08800080200046Smart kit BasicSKT-0112023-05-11
08800080200053Smart kit BasicSKT-0212023-05-11
08800080200060Smart kit BasicSKT-0612023-05-11
08800080201012Smart kit ProSKT-140602023-05-11
08800080201029Smart kit ProSKT-240602023-05-11
08800080201036Smart kit ProSKT-124402023-05-11
08800080201043Smart kit ProSKT-224402023-05-11
08800080201050Smart kit ProSKT-12460 2023-05-11
08800080201067Smart kit ProSKT-224602023-05-11
08800080202019AdinizerSKT-AN-1002023-05-11
08800080202026AdinizerSKT-AN-2002023-05-11
08800080202033AdinizerSKT-AN-4002023-05-11
08800080202040AdinizerSKT-AN-6002023-05-11
08800080202057AdinizerSKT-AN-12002023-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380211218Aero-MedAERO-MED, LLCNNL2026-03-20
50885380211216Aero-MedAERO-MED, LLCNNL2026-03-20
10850074089053ClinicoLabSurgyco LLCNNL2025-09-10
08800080220020ACS Combo-B IncubatorBSL Co.,LtdNNL2025-05-07
04038917085403Cool transport containerSarstedt Aktiengesellschaft & Co.KGNNL2022-11-30
00850045030025MagBio Genomics, Inc. Magbio Genomics, Inc.NNL2022-09-13
00850045030032MagBio Genomics, Inc. Magbio Genomics, Inc.NNL2022-09-13
00850045030049MagBio Genomics, Inc. Magbio Genomics, Inc.NNL2022-09-13
00850045030056MagBio Genomics, Inc. Magbio Genomics, Inc.NNL2022-09-13
00850040712018Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712032Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712063Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712070Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712001Mawi Dna TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10850040712015Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712025Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10850040712039Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712049Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
00850040712056Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10850040712060Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10850040712077Mawi DNA TechnologiesMawi Dna Technologies, LLCNNL2022-04-06
10885380170805CARDINAL HEALTHCardinal Health 200, LLCNNL2020-05-30
10885380169618CARDINAL HEALTHCardinal Health 200, LLCNNL2019-03-11
10885380169625CARDINAL HEALTHCardinal Health 200, LLCNNL2019-03-11
10885380168833CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20
10885380168840CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20
10885380168871CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20
10885380168888CARDINAL HEALTHCardinal Health 200, LLCNNL2018-12-20