FDA.report

Batrik Bean Bag w/ shoulder cutout

Primary DI
00690521010239
Brand
Batrik Bean Bag w/ shoulder cutout
Company
Batrik Medical Manufacturing Inc
Model
82-003
Catalog number
82-003
Device description
Blue Cloud Bean Bag w/ shoulder cutout
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
CCXSupport, Patient Position

Product Code Classifications

CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00690521010239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00690521010239006905210102396905210102390690521010239

GMDN Terms

TermDefinition
Anti-fatigue floor matA pad designed to be stood on by healthcare staff to reduce fatigue associated with standing for prolonged periods (e.g., during procedures). It is designed to cushion the feet of the user and may include additional secondary features (e.g., non-slip, antimicrobial surface). This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient temperature and away from direct sunlight

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
514-631-7988info@surgmed.com

Regulatory Flags

DUNS number
243880700
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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