DEVICE: Sage (00618029980045)
Device Identifier (DI) Information
Device Characteristics
MR Safe | |
No | |
Yes | |
Yes | |
No | |
Yes | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61850 | Absorbent underpad, non-antimicrobial, single-use |
A flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.
|
Active | false |
37480 | General-purpose patient lifting system sling/harness |
A general-purpose lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position with their body (back, arms, buttocks and upper legs) held within the sling for transfer and (re)positioning. It is typcially constructed of straps, belts and material in which the occupant is cradled and contained during the lifting process; some types may employ additional straps, belts or vest-like harnesses to safely secure the occupant within the device. It typically has lifting straps or eyes that attach to a two-point, three-point or four-point spreader bar. This is a reusable device.
|
Active | false |
37163 | Patient transfer sliding mat |
A manual device typically in the form of an open roll mat or flat sheet designed to be used by healthcare professionals to assist in the physical movement and transfer of a patient (e.g., hospitalized, disabled, geriatric) from one place to another. The device typically has no lifting capabilities and utilizes sliding techniques to move the patient. It is typically designed using low-friction artificial fibres and intended to be slid under the patient who is then gently pushed by attending staff to glide across the surface of the device.
|
Active | false |
47452 | Bed pillow, single-use |
A sealed cloth case stuffed with soft material (e.g., foam rubber) designed to support the head especially during rest and sleep in bed; it can also be used to support another part of the body to provide comfort (e.g., behind the back when in a sitting position, under a leg for support). It may or may not be used with a pillowcase. It does not include antimicrobial/probiotic materials but might provide a physical barrier (e.g., tight weave) to dust mites. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMP | Protector, skin pressure |
KME | BEDDING, DISPOSABLE, MEDICAL |
FSA | LIFT, PATIENT, NON-AC-POWERED |
FMR | DEVICE, TRANSFER, PATIENT, MANUAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 65.0 Inch |
Width: 37.0 Inch |
Device Record Status
01772b08-a6f9-4b69-bbb9-aa8d9d9f470e
July 26, 2022
7
July 01, 2019
July 26, 2022
7
July 01, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
50618029980040 | 5 | 00618029980045 | 2019-08-14 | Not in Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)323-2220
customer-service-spcl@sageproducts.com
customer-service-spcl@sageproducts.com