FDA.reportPublic FDA data

SWIVEL PARALLEL ㄇ PIECE W/PORT;OD:22mm

Primary DI
04716770121321
Brand
SWIVEL PARALLEL ㄇ PIECE W/PORT;OD:22mm
Company
BESMED HEALTH BUSINESS CORP.
Model
CT-12132
Device description
SWIVEL PARALLEL ㄇ PIECE W/PORT;OD:22mm
Published
2017-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04716770121321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04716770121321047167701213214716770121321

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration tubingA length of flexible tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2) or an O2 enriched gas to a mask or nasal cannula, typically during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658023775
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04716770701127HME W/Luer lock port (Dead space 45ml)FL-701122026-02-11
04716770701158Angled HME with luer lock portFL-701152026-02-11
04716770702230Bacterial Filter (Dead space 32ml)FL-702232026-02-11
14716770703029HMEF W/Luer lock port (Dead space 45ml)FL-703022026-02-11
14716770703036HMEF W/Luer lock port (Dead space 60ml)FL-703032026-02-11
14716770703067HMEF (Dead space 60ml)FL-703062026-02-11
04716770834221ICU gas sampling packOT-834222022-08-08
04716770834238ICU gas sampling pack with flowmeterOT-834232022-08-08
04716770144306Straight Connector 15F/22M, 15M W/PORT & CAPCT-143302021-01-07
04716770857398FLOW SENSOR, ADULTPO-857392021-01-07
04716770790015Elbow connetor 18MM ID for nebulizerMP-790012017-12-13
04716770791043MOUTH PIECE (OD:18mm,22mm)MP-791042017-12-13
04716770791081MOUTH PIECE(OD:22mm)MP-791082017-12-13
04716770791098MOUTH PIECE (ID:18mm, OD:19.5mm)MP-791092017-12-13
04716770791203Nebulizer,pacifierMP-791202017-12-13
04716770000176SILICONE ADULT 1000ML RESUSCITATOR W/ POP-OFF 60CM H2O, L TYPE ADAPTERRE-231722016-05-23
04716770000183 SINGLE USE ADULT 1000ML RESUSCITATOR W/O POP-OFFRE-234122016-05-23
04716770000190 SINGLE USE CHILD 500ML RESUSCITATOR W/ POP-OFF 40CM H2O (ALL IN ONE-INTAKE VALVRE-245102016-05-23
04716770244372SINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF , 60cm H2O & MANOMETER PORTRE-244372016-05-23
04716770005607Digital tens one channelBE-5602016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628101548254OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101559618OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101595708OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101599980OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101622374OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631543OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631567OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631574OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631628OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631635OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631642OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631673OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631680OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631703OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631710OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631727OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631734OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631741OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631758OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631802OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631819OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631826OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631833OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631871OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631888OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631918OhioOHIO MEDICAL, LLCBYX2026-03-24
00628101631925OhioOHIO MEDICAL, LLCBYX2026-03-23
00628101631932OhioOHIO MEDICAL, LLCBYX2026-03-23
00628101631949OhioOHIO MEDICAL, LLCBYX2026-03-23
00848530108632CPAP TubingSUNSET HEALTHCARE SOLUTIONS, INC.BYX2026-03-19