FDA.report

AMD-RITMED

Primary DI
00686864055174
Brand
AMD-RITMED
Company
AMD Medicom Inc
Model
A1090
Catalog number
A1090
Device description
Ritmed Disposable Paper Pillow Case, White - 21" x 30"
Published
2021-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KMEBedding, Disposable, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20686864055178PrimaryGS10
00686864055174Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686405517820686864055178
00686864055174006868640551746868640551740686864055174

GMDN Terms

TermDefinition
Basic pillowcase, single-useA protective envelope for a pillow typically made of a thin-textile or reinforced-paper material that creates a physical barrier to soiling and cross-contamination. It does not include antimicrobial or dust mite barrier/prevention properties. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).

Device Sizes

TypeValueUnit
Length30Inch
Width21Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(514)636-6262mdasilva@medicom.ca

Regulatory Flags

DUNS number
256880576
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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20686864061735MEDICOM224415.002224415.0022025-11-20
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20686864061384Medicom AssureTouch9940-B9940-B2025-04-24
00686864061397Medicom AssureTouch9940-C9940-C2025-04-24
20686864061407Medicom AssureTouch9940-D9940-D2025-04-24
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