Mini-PRO Pediatric Restraint System (with Modified X-Restraints)

Primary DI
07613327679410
Brand
Mini-PRO Pediatric Restraint System (with Modified X-Restraints)
Company
STRYKER CORPORATION
Model
641005550001
Catalog number
641005550001
Device description
Pediatric restraint that consists of a support seat, 5-point harness, color coded straps to attach to modified X restraints, and an integrated head support that can be activated when needed. Mini-PRO is designed to support and transport a 4 to 108 lbs (1.81 to 48.99 kgs) patient when transported alone or a 4-22 lbs (1.81-9.98 kgs) when transported via co-transport. Mini-PRO is compatible with Stryker ambulance cots Power-PRO 2, Power-PRO XT, Power-PRO TL, and Performance-PRO.
Published
2026-08-21
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

Product Codes#

Code, Name table
CodeName
FPOSTRETCHER, WHEELED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPOStretcher, WheeledGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327679410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327679410076133276794107613327679410

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, reusableA non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
078470558
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

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