FDA UDI
In Commercial Distribution
🇺🇸 United States
HCS
DI: 00810132043000
·
Model: 81801
·
Concordance Healthcare Solutions LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- HCS
- Primary DI
- 00810132043000
- Version / Model
- 81801
- Company Name
- Concordance Healthcare Solutions LLC
- Labeler DUNS
- 080220245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-23
- Public Version
- 1
- Public Version Date
- 2026-02-02
- Public Version Status
- New
- Public Device Record Key
- 07222e3b-9890-4adf-aeca-5e4e4b03b565
Device Description
Transfer Repositioning Sheet w/Straps, 35" x 55"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| IKX | Aid, Transfer | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37165 | Patient transfer/turning sheet, single-use | A manual device in the form of a non-inflatable sheet or mat intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810132043007 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00810132043000 | GS1 |