FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sage
DI: 00618029980045
·
Model: 700-115
·
SAGE PRODUCTS, LLC
Product Codes
4
GMDN Terms
4
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sage
- Primary DI
- 00618029980045
- Version / Model
- 700-115
- Catalog Number
- 700-115
- Company Name
- SAGE PRODUCTS, LLC
- Labeler DUNS
- 054326178
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-01
- Public Version
- 7
- Public Version Date
- 2022-07-26
- Public Version Status
- Update
- Public Device Record Key
- 01772b08-a6f9-4b69-bbb9-aa8d9d9f470e
- Distribution End Date
- 2019-08-14
Device Description
Sage AirTAP LC
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMP | Protector, skin pressure | General Hospital | 880.6450 | 1 |
| KME | BEDDING, DISPOSABLE, MEDICAL | General Hospital | 880.6060 | 1 |
| FSA | LIFT, PATIENT, NON-AC-POWERED | General Hospital | 880.5510 | 1 |
| FMR | DEVICE, TRANSFER, PATIENT, MANUAL | General Hospital | 880.6785 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
| 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. | No | Active |
| 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. | No | Active |
| 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50618029980040 | GS1 | case | 5 | Not in Commercial Distribution | 2019-08-14 |
| Primary | 00618029980045 | GS1 |
Customer Contacts
- Phone
- +1(800)323-2220
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 65.0 | Inch | |
| Width | 37.0 | Inch |