FDA.report

Midmark

Primary DI
00841709109669
Brand
Midmark
Company
MIDMARK CORPORATION
Model
626-005
Catalog number
626-005
Device description
The examination table is intended to be used as a chair / table to provide positioning and support of patients during general examination procedures conducted by medical professionals. With the addition of the integrated digital scale, the examination table is additionally intended to be used for regular monitoring to assess patient weight change, as well as measuring patient weight to assist medical diagnosis. The integrated digital scale is not intended to be used for patients that weigh less than 30 pounds (13.6 kilograms) or more than 650 pounds (295 kilograms).
Published
2019-10-04
Public version status
Update
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
GBBCHAIR, SURGICAL, AC-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
GBBChair, Surgical, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841709109669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709109669008417091096698417091096690841709109669

GMDN Terms

TermDefinition
General examination/treatment chair, electricA mains electricity (AC-powered) device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms; it may have an integrated weighing scale. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius90 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)643-6275support@midmark.com

Regulatory Flags

DUNS number
005036025
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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

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00841709121920MidmarkLT-1400-096LT-1400-0962026-03-19
00841709122088MidmarkLT-1600-108LT-1600-1082026-03-19
00841709122217Midmark029-11924-02LT-15002026-03-19
00841709122132Midmark153839-013153839-0132026-03-11
00841709122149Midmark153720-011153720-0112026-03-11
00841709122156Midmark153740-012153740-0122026-03-11
00841709122163Midmark153740-013153740-0132026-03-11
00841709122170Midmark153740-014153740-0142026-03-11
00841709121913MidmarkLT-1300-001LT-1300-0012026-03-10
00841709121937MidmarkLT-1400-102LT-1400-1022026-03-10
00841709121944MidmarkLT-1400-108LT-1400-1082026-03-10
00841709121951MidmarkLT-1400-114LT-1400-1142026-03-10
00841709121968MidmarkLT-1400-120LT-1400-1202026-03-10
00841709121975MidmarkLT-1400-126LT-1400-1262026-03-10
00841709121982MidmarkLT-1400-132LT-1400-1322026-03-10
00841709121999MidmarkLT-1500-096LT-1500-0962026-03-10
00841709122002MidmarkLT-1500-102LT-1500-1022026-03-10
00841709122019MidmarkLT-1500-108LT-1500-1082026-03-10
00841709122026MidmarkLT-1500-114LT-1500-1142026-03-10
00841709122033MidmarkLT-1500-120LT-1500-1202026-03-10

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