FDA.reportPublic FDA data

"Rotating Flange With Textured Grip Grab Bar 32"""

Primary DI
00616784031514
Brand
"Rotating Flange With Textured Grip Grab Bar 32"""
Company
Dynarex Corporation
Model
10315
Published
2019-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILSAdaptor, Hygiene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILSAdaptor, HygienePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784031514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784031514006167840315146167840315140616784031514

GMDN Terms#

Term, Definition table
TermDefinition
Parallel bar exerciser, non-poweredAn exercise apparatus designed to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk. It typically consists of two parallel wooden or steel handrails each one supported by two poles and base plates; the user holds the bars, which may be manually height and width-adjustable, thus relieving his/her weight when walking. The device is intended to improve the user?s balance as well as coordination and flexibility; additionally, it can improve the muscle strength in the lower limbs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784124810Transducer Covers, For Ultrasound Imaging Systems, 5.3 cm x 20 cm12482016-09-24
00616784426211Piston Irrigation Syringe,Ring Top Syringe with Protective Cap Tubing Adaptor42622021-09-01
00616784020518Vivid-Essential Rollator with 6" Casters, Red102052019-10-07
00616784020617Vivid-Essential Rollator with 6" Casters, Blue102062019-10-07
00616784703015"IV Administration Set, 10 mL, Non-Toxic, 83"" "70302016-09-24
00616784703312"IV Administration Set, Non-Toxic, 15 mL, 106"" (269.2 cm)"70332016-09-24
00616784703411"IV Administration Set, 15 mL, Non-Toxic, 73"" (185.4 cm)"70342016-09-24
00616784703718"IV Administration Set, 15 mL, Non-Toxic, 15-Drops /mL, 92"" (234.7 cm)"70372016-09-24
00616784704814"IV Administration Set, 20 mL, Non-Toxic, 20-Drops/mL, 100"" (254.0 cm) "70482016-09-24
00616784704913"IV Administration Set, 20 mL, Non-Toxic, 92"" (233.7 cm)"70492016-09-24
00616784705118"IV Administration Set, 60 mL, Non-Toxic, 60-Drops/ mL, 83"" (210.8 cm) "70512016-09-24
00616784705217"IV Administration Set, 60 mL, Non-Toxic, 60-Drops/mL, 78"" (198.1 cm) "70522016-09-24
00616784705415Needleless PRN Luer Connectors, Non-Toxic70542016-09-24
00840117334502Pre-Filled Saline Flush Syringe, 5 mL70582024-03-07

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Primary DI, Brand, Company table
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