FDA.report

35A-IT Incubator Transporter

Primary DI
00190790001124
Brand
35A-IT Incubator Transporter
Company
FERNO-WASHINGTON, INC.
Model
0063120
Device description
35A-IT Incubator Transporter, DS
Published
2016-08-22
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
FPOStretcher, Wheeled

Product Code Classifications

CodeDeviceSpecialtyClass
FPOStretcher, WheeledGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190790001124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190790001124001907900011241907900011240190790001124

GMDN Terms

TermDefinition
Ambulance stretcher, manualA manually-operated device consisting of a platform mounted on a wheeled frame designed for use by emergency medical services (EMS) primarily to facilitate easy transport of a recumbent patient to and from ambulance vehicles (e.g., automobiles, aeroplanes, helicopters, boats); it does not include a powered or powered-assisted lifting mechanism. It is typically constructed of lightweight materials and has an undercarriage that opens and folds when it is removed from or pushed into the ambulance; it also usually includes locking devices that match with the locking/docking devices in the ambulance.

Sterilization Methods

Method

Contacts

PhoneEmail
937-382-1685tscoordinator@ferno.com

Regulatory Flags

DUNS number
004239034
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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00190790000004iN∫X®00158032016-08-22
00190790000011iN∫X®00158022016-08-22
00190790000172PowerFlexx®00156512016-08-22
00190790000189PowerFlexx®00156542016-08-22
00190790000202PowerFlexx®00157292016-08-22
00190790000219PowerFlexx®00157302016-08-22
00190790000226PowerFlexx®00157962016-08-22
00190790000233PowerFlexx®00157972016-08-22
00190790000240PowerFlexx®00157992016-08-22

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