FDA UDI
In Commercial Distribution
🇺🇸 United States
Ocean 24" XL Dir. Lock
DI: 04028698132564
·
Model: 1603080
·
INVACARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ocean 24" XL Dir. Lock
- Primary DI
- 04028698132564
- Version / Model
- 1603080
- Catalog Number
- 1603080, 1603157
- Company Name
- INVACARE CORPORATION
- Labeler DUNS
- 076916246
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-18
- Public Version
- 1
- Public Version Date
- 2019-10-28
- Public Version Status
- New
- Public Device Record Key
- a04a3fe4-0afb-4e5f-94ce-6576b38dcf79
Device Description
Ocean Ergo XL Dir. Lock
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| INN | CHAIR, ADJUSTABLE, MECHANICAL | Physical Medicine | 890.3100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34936 | Shower seat, non-powered | A non-powered device designed to be sat upon by a patient (adult or child) while washing in a shower, or other washing facility (e.g., bath). The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device may be in the form of a portable chair/stool or a fixed seat (e.g., wall-mounted), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof materials (e.g., plastic and metal-coated materials). It may be used in a hospital, institution, or home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04028698132564 | GS1 |
Customer Contacts
- Phone
- +1(440)329-6000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 |