FDA.report

Bella Lite Glove

Primary DI
00035664030438
Brand
Bella Lite Glove
Company
BSN MEDICAL, INC.
Model
7769713
Device description
BELLA LITE 15-20 MM HG GLOVES SIZE 4 BLACK 1 UPC
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MDRBINDER, MEDICAL, THERAPEUTIC

Product Code Classifications

CodeDeviceSpecialtyClass
MDRBinder, Medical, TherapeuticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00035664030438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00035664030438000356640304380356640304380035664030438

GMDN Terms

TermDefinition
Compression/pressure sock/stocking, reusableA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)537-1063BSN.ORDERS@BSNMEDICAL.COM

Regulatory Flags

DUNS number
026301221
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
false
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 DIBrandModelCatalogPublished
04042809649796ZONAS® by Actimove®65001-0465001-042025-09-02
04042809818581ZONAS® by Actimove®65001-0165001-012025-09-02
04042809662764JOBST forMen60520-0060520-002025-07-01
04042809663143JOBST forMen60520-0160520-012025-07-01
04042809687828JOBST forMen60520-2060520-202025-07-01
04042809702033JOBST forMen60422-0360422-032025-07-01
04042809702040JOBST forMen60422-0560422-052025-07-01
04042809702057JOBST forMen60422-0660422-062025-07-01
04042809841657JOBST forMen60520-0260520-022025-07-01
04042809841664JOBST forMen60520-0360520-032025-07-01
04042809841671JOBST forMen60520-0460520-042025-07-01
04042809841688JOBST forMen60520-0560520-052025-07-01
04042809841695JOBST forMen60520-0660520-062025-07-01
04042809841701JOBST forMen60520-0760520-072025-07-01
04042809841718JOBST forMen60520-0860520-082025-07-01
04042809841725JOBST forMen60520-0960520-092025-07-01
04042809841732JOBST forMen60520-1060520-102025-07-01
04042809841749JOBST forMen60520-1160520-112025-07-01
04042809841756JOBST forMen60532-0060532-002025-07-01
04042809841763JOBST forMen60532-0160532-012025-07-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00636257043066MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043073MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043080MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043097MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043103MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043110MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043127MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043134MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043141MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043158MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043165MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043172MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043189MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043196MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043202MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257043219MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047507MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047514MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047521MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047538MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047545MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047552MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047569MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047576MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047583MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00636257047590MEDIMEDI MANUFACTURING, INC.MDR2026-01-23
00745129331610Cflex Reduce Full Leg SM SM SM Tall Left BeigeSIGVARIS INCMDR2025-08-15
00745129331627Cflex Reduce Full Leg LG LG LG Tall Left BlackSIGVARIS INCMDR2025-08-15
00745129331634Cflex Reduce Full Leg LG LG LG Tall Left BeigeSIGVARIS INCMDR2025-08-15
00745129331641Cflex Reduce Full Leg SM SM SM Reg Left BlackSIGVARIS INCMDR2025-08-15