FDA.reportPublic FDA data

Bioseal

Primary DI
10630094197033
Brand
Bioseal
Company
BIOSEAL
Model
19703/50
Device description
Levin Tube 14FR
Published
2020-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAZTUBING, NONINVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094197033PackageGS150In Commercial Distribution
00630094197036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009419703310630094197033
00630094197036006300941970366300941970360630094197036

GMDN Terms#

Term, Definition table
TermDefinition
Nasogastric feeding tubeA sterile, thin, flexible, hollow cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily for enteral feeding and the administration of medications, either by gravity or with a pump; it may also be used for aspiration of gastric contents (e.g., gastric secretions). It is typically a single lumen, rubber or plastic tube of various diameters (typically smaller than those of nasogastric tubes intended primarily for decompression) with circular markings that serve as insertion guides. It is frequently used for very ill or comatose patients. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186968939
Device count
1
DM exempt
true
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
00630094481029Bioseal Inc.DURA102/1002025-05-29
00630094481234Bioseal Inc.DURA123/1002025-05-29
00630094483009Bioseal Inc.DURA300/1002025-05-29
00630094485058Bioseal Inc.DURA505/1002025-05-29
00630094485126Bioseal Inc.DURA512/1002025-05-29
00630094487021Bioseal Inc.DURA702/1002025-05-29
00630094487052Bioseal Inc.DURA705/1002025-05-29
00630094487304Bioseal Inc.DURA730/1002025-05-29
00630094489025Bioseal Inc.DURA902/1002025-05-29
00630094480503Bioseal Inc.DURA050/1002025-05-28
10630094292240Bioseal Inc.32-922-4/202024-01-10
10630094335404Bioseal Inc.33-540/202024-01-10
10630094055111Bioseal Inc.551S/202024-01-29
10630094055135Bioseal Inc.551L/202024-01-29
10630094055142Bioseal Inc.551M/202024-01-29
10630094055197Bioseal Inc.551R/202024-01-29
10630094061501Bioseal Inc.6150/252024-01-29
10630094061518Bioseal Inc.6151/252024-01-29
10630094061525Bioseal Inc.6152/502024-01-29
10630094064243Bioseal Inc.6424/1202024-01-29

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Primary DI, Brand, Company table
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04573316388538KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
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00849296016971WelmedWELMED INC.GAZ2026-02-15
00849296016988WelmedWELMED INC.GAZ2026-02-15
00849296016995WelmedWELMED INC.GAZ2026-02-15
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00849296017015WelmedWELMED INC.GAZ2026-02-15
00849296017022WelmedWELMED INC.GAZ2026-02-15
00849296017039WelmedWELMED INC.GAZ2026-02-15
50885380072350CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-13
10885380172519CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172526CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172533CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172557CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172571CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172595CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
00810130455478Medco Manufacturing IncMedco Manufacturing LLCGAZ2025-09-11