FDA.reportPublic FDA data

Sample Container

Primary DI
16971381257585
Brand
Sample Container
Company
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
Model
SC-60
Device description
Bronchus Sampler is composed of the sampler connector, flow switch, silicone plug and sample container. The Bronchus Sampler is designed as accessory to the Single-use Broncho Videoscope, and intended to enable aspiration and collection of fluid sample from the bronchial or alveolar part of the lung.The sample container is used to connect to the sampler connector, and holds the retrieved sample.
Published
2024-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMHContainer, Specimen, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971381257585PackageGS110In Commercial Distribution
26971381257582PackageGS1100In Commercial Distribution
06971381257588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697138125758516971381257585
2697138125758226971381257582
06971381257588069713812575886971381257588

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544519831
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
06971381254228Single-use Flexible UreteroscopeSUV-2C-B2026-07-16
06971381252736Single-use Extraction BasketsEBF-1529CG2024-12-06
06971381252743Single-use Extraction BasketsEBF-1511CG2024-12-06
06971381252750Single-use Extraction BasketsEBF-1511SG2024-12-06
06971381252767Single-use Extraction BasketsEBF-1506SG2024-12-06
06971381252774Single-use Extraction BasketsEBF-1506CG2024-12-06
06971381252781Single-use Extraction BasketsEBF-1507SG2024-12-06
06971381252798Single-use Extraction BasketsEBF-1507CG2024-12-06
06971381252804Single-use Extraction BasketsEBF-1508SG2024-12-06
06971381252811Single-use Extraction BasketsEBF-1508CG2024-12-06
06971381252828Single-use Extraction BasketsEBF-2029SG2024-12-06
06971381252835Single-use Extraction BasketsEBF-2029CG2024-12-06
06971381252903Single-use Extraction BasketsEBF-2006SG2024-12-06
06971381252910Single-use Extraction BasketsEBF-2006CG2024-12-06
06971381252927Single-use Extraction BasketsEBF-2007SG2024-12-06
06971381252934Single-use Extraction BasketsEBF-2007CG2024-12-06
06971381252941Single-use Extraction BasketsEBF-2008SG2024-12-06
06971381252958Single-use Extraction BasketsEBF-2008CG2024-12-06
06971381252729Single-use Extraction BasketsEBF-1529SG2024-12-06
06971381253146Single-use Biopsy ForcepsBFUW-1029P-YG2023-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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H1084306551CorningCorning IncorporatedFMH2026-01-26
H1083540141Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540171Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540201Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H108117391CorningCorning IncorporatedFMH2026-01-14
H108117041CorningCorning IncorporatedFMH2025-10-28
10192253051490DoverCardinal Health 200, LLCFMH2025-09-30
10192253051513DoverCardinal Health 200, LLCFMH2025-09-30
10198459304637MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-08-18
10198459382963MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-07-02
10080196035298MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-06-12
10198459351327MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FMH2025-06-02
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10193489013467MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-03-20
10198459295270Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-16
10198459277122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-03-02
10192253051636PrecisionCardinal Health 200, LLCFMH2025-02-19
10198459247897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10198459249303Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2025-02-02
10197344039517MEDLINEMEDLINE INDUSTRIES, INC.FMH2025-01-31
10198459203176Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-12-08
10198459190544Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-24
10198459179860Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
10198459181702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FMH2024-11-17
H1084313371CorningCorning IncorporatedFMH2024-10-29
H1084313381CorningCorning IncorporatedFMH2024-10-29