FDA.reportPublic FDA data

Meridian Medical

Primary DI
30815067040231
Brand
Meridian Medical
Company
Meridian Medical
Model
#6003M
Device description
FULL LEG INSERT MED
Published
2016-10-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30815067040231PackageGS120Not in Commercial Distribution
00815067040230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081506704023130815067040231
00815067040230008150670402308150670402300815067040230

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent venous compression systemA system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-572-1962CustomerService@compasshealthbrands.com
800-376-7263CustomerService@compasshealthbrands.com

Regulatory Flags#

DUNS number
800450475
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30815067040040Meridian Medical#6003L2016-10-19
30815067040118Meridian Medical#60022016-10-19
30815067043423Meridian Medical#6003L-42017-02-17
30815067043430Meridian Medical#6004M2017-02-17
30815067040125Meridian Medical#6104M-S2016-10-19
30815067040194Meridian Medical#6103M-S2016-10-19
30815067040200Meridian Medical#6102-S2016-10-19
30815067040217Meridian Medical#6103S-S2016-10-19
30815067040224Meridian Medical#6103L-S2016-10-19
30815067042556Meridian Medical1002F2016-10-18
30815067042563Meridian Medical11052016-10-18
30815067042587Meridian Medical51022016-10-18
30815067042594Meridian Medical3102M2016-10-18
30815067040033Meridian Medical10012016-10-18
30815067040057Meridian Medical4253E2016-10-18
30815067040163Meridian Medical10032016-10-18
30815067040170Meridian Medical10022016-10-18
30815067042723MeridianQ52016-11-28
30815067042846Meridian Medical4840-392016-10-18
30815067043454Meridian Medical4253EB2017-03-15

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Primary DI, Brand, Company table
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